FrancophonIA/ELRC3.0 huggingface dataset:
English: Around 83% of bleeding episodes resolved with one injection.
Danish: Ca. 83 % af blødningsepisoderne forsvandt efter én injektion.
English: What are the risks associated with Adynovi?
Danish: Hvilke risici er der forbundet med Adynovi?
English: In the second study in 66 children aged below 12 years, all patients were given Adynovi as a twiceweekly preventive treatment for around 6 months.
Danish: I den anden undersøgelse af 66 børn under 12 år fik alle patienter Adynovi som forebyggende behandling to gange om ugen i ca. 6 måneder.
English: The company that markets Adynovi will conduct a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other organs.
Danish: Virksomheden, der markedsfører Adynovi, skal gennemføre en undersøgelse af de mulige virkninger af PEG-ophobning i hjernens plexus choroideus og andre organer.
English: Adynovi must not be used in patients who are hypersensitive (allergic) to rurioctocog alfa pegol or the related substance octocog alfa or to any of the other ingredients of the medicine, nor in those with known allergy to mouse or hamster proteins.
Danish: Adynovi må ikke anvendes hos patienter, der er allergiske over for rurioctocog alfa pegol eller det relaterede stof octocog alfa eller et eller flere af de andre indholdsstoffer i lægemidlet, og heller ikke hos personer med kendt allergi over for muse- eller hamsterproteiner.
English: Around 96% of bleeding episodes resolved with one or two injections of Adynovi.
Danish: Ca. 96 % af blødningsepisoderne forsvandt efter en eller to injektioner af Adynovi.
English: Adynovi can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.
Danish: Adynovi udleveres kun efter recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i behandling af hæmofili.
English: In a study involving 138 adults and adolescents aged 12 years or above, 120 patients given Adynovi as a twice-weekly preventive treatment had, on average, around 4 bleeding episodes a year, and 17 patients given Adynovi for treating bleedings ‘on demand' had around 43 bleeding episodes a year.
Danish: I en undersøgelse af 138 voksne og unge i alderen 12 år og derover fik 120 patienter Adynovi to gange om ugen som forebyggende behandling, og de oplevede i gennemsnit ca. 4 blødningsepisoder om året, mens 17 patienter, der fik Adynovi til behandling af blødning efter behov, oplevede ca. 43 blødningsepisoder om året.
English: The active substance in Adynovi, rurioctocog alfa pegol, works in the body in the same way as human factor VIII.
Danish: Det aktive stof i Adynovi, rurioctocog alfa pegol, virker på samme måde i kroppen som kroppens egen faktor VIII.
English: Following treatment with factor VIII products, including Adynovi, some patients may develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Danish: Efter behandling med faktor VIII-lægemidler, herunder Adynovi, kan nogle patienter danne antistoffer mod faktor VIII, hvilket medfører, at lægemidlet ikke længere virker, og at kontrollen med blødning svigter.
English: For more information about treatment with Adynovi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Adynovia, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In addition, when bleeding did occur, Adynovi was rated excellent or good at treating around 96% of bleeding episodes.
Danish: Når blødning forekom, blev Adynovi desuden vurderet som fremragende eller godt til behandling af ca. 96 % af blødningsepisoderne.
English: Adynovi contains the active substance rurioctocog alfa pegol.
Danish: Adynovi indeholder det aktive stof rurioctocog alfa pegol.
English: When bleeding occurred, Adynovi was rated excellent or good at treating around 90% of episodes.
Danish: Når blødning forekom, blev Adynovi vurderet som fremragende eller godt til behandling af ca. 90 % af blødningsepisoderne.
English: Studies show that Adynovi is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is comparable to that of other factor VIII products.
Danish: Undersøgelser viser, at Adynovi er effektivt til at forebygge og behandle blødningsepisoder hos patienter med hæmofili A, og dets sikkerhed er sammenlignelig med andre faktor VIII-produkter.
English: Adynovi is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by lack of a clotting protein called factor VIII.
Danish: Adynovi er et lægemiddel til behandling og forebyggelse af blødning hos patienter med den arvelige blødningsforstyrrelse hæmofili A, der skyldes mangel på blodstørkningsproteinet faktor VIII.
English: For practical information about using Adynovi, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Adynovi, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Adynovi used?
Danish: Hvordan anvendes Adynovi?
English: However, part of the active substance in Adynovi (called PEG) may accumulate in the body, including in a structure in the brain called the choroid plexus, following long-term treatment.
Danish: Efter langvarig behandling kan en del af det aktive stof i Adynovi (det såkaldte PEG) imidlertid ophobes i kroppen, herunder i årenettet (plexus choroideus) i hjernen.
English: Adynovi is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Danish: Adynovi leveres som et pulver med opløsningsvæske (solvens), der blandes sammen til en opløsning, som gives ved injektion i en blodåre.
English: Adynovi has been shown in two main studies to be effective at preventing and treating bleeding episodes in patients with severe haemophilia who were previously treated with other factor VIII products.
Danish: Det er i to hovedundersøgelser påvist, at Adynovi forebygger og behandler blødningsepisoder hos patienter med svær hæmofili, som tidligere blev behandlet med andre faktor VIII-produkter.
English: How does Adynovi work?
Danish: Hvordan virker Adynovi?
English: What benefits of Adynovi have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Adynovi?
English: Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily.
Danish: Patienter med hæmofili A mangler faktor VIII, der er et protein, som er nødvendigt for, at blodet kan størkne på normal vis, og de har derfor en øget tendens til blødning.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adynovi have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Adynovi.
English: If these changes were observed, treatment should be stopped.
Danish: Hvis disse ændringer er observeret, skal behandlingen stoppes.
English: There is no gender effect on pharmacokinetic parameters.
Danish: Der er ingen kønsrelateret virkning på de farmakokinetiske parametre.
English: Detailed information on this 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: Systemic exposure was 1.5 times higher in fed dogs.
Danish: Systemisk eksponering var 1,5 gange højere hos fodrede hunde.
English: The MTP is pivotal for the absorption and distribution of fat.
Danish: MTP er væsentlig for absorption og distribution af fedt.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the bottle.
Danish: Brug ikke dette vetrinærlægemiddel efter den udløbsdato, der står på flasken.
English: Additionally, dirlotapide was highly protein bound (>99%) in dog plasma.
Danish: Desuden var dirlotapid stærkt proteinbundet (>99 %) i hundeplasma.
English: Ingestion can be harmful to children and pregnant women.
Danish: Indtagelse kan være skadeligt for børn og gravide kvinder.
English: Mean oral bioavailability values were approximately 24% - 41% for fed dogs and 22% in fasted dogs.
Danish: Den gennemsnitlige orale biotilgængelighed var omkring 24 %-41 % hos fodrede hunde og 22 % hos fastede hunde.
English: EU/2/07/071/002 (50ml) EU/2/07/071/003 (150ml)
Danish: EU/2/07/071/001 (20 ml) EU/2/07/071/002 (50 ml) EU/2/07/071/003 (150 ml)
English: This is the starting dose for a 5 kg dog.
Danish: Dette er start dosis til en 5 kg hund.
English: To be used as part of an overall weight management programme which also includes appropriate dietary changes and exercise
Danish: Bruges som en del af et samlet vægtkontrolprogram, som også omfatter passende kostforandringer og motion.
English: In a 3-month study, exposures were 2 times higher at Day 29 but returned to Day 1 values at days 56 and 87.
Danish: I et 3 måneders studie var koncentrationen dobbelt så høj på dag 29, men vendte tilbage til dag-1 værdier på dag 56 og dag 87.
English: The veterinarian will examine your dog at the beginning of treatment and recommend a starting dose.
Danish: Dyrlægen vil undersøge hunden ved begyndelsen af behandlingen og anbefale en startdosis.
English: In a 14-day repeated dose study, AUC increased 3-fold from Day 1to Day 14.
Danish: I et 14-dages studie med gentagne doseringer steg AUC med en faktor 3 fra dag 1 til 14.
English: In a radiolabeled metabolism study, the primary route of excretion was via the faeces with minimal excretion via urine (<1%).
Danish: I et metabolismestudie med radioaktiv mærkning var den primære eliminationsvej via fæces med minimal elimination via urin (<1 %).
English: The effect is mainly mediated indirectly due to reduced feed intake during therapy.
Danish: Effekten er hovedsageligt indirekte på grund af reduceret foderindtagelse under behandlingen.
English: These adjustments should be continued until the weight targeted at the start of therapy is achieved.
Danish: Disse justeringer fortsættes, indtil det tilstræbte mål for vægten ved starten af behandlingen er opnået.
English: The veterinary medicinal product is not miscible with water.
Danish: Veterinærlægemidlet er ikke blandbart med vand.
English: Dirlotapide is a potent selective inhibitor of the Microsomal Triglyceride transfer Protein (MTP).
Danish: Dirlotapid er en potent selektiv hæmmer af Microsomal-Triglyceride-transfer-Protein (MTP).
English: Fertility studies have not been conducted in the target species.
Danish: Fertilitetsstudier er ikke udført i målgruppen.
English: As an aid in the management of overweight and obesity in adult dogs.
Danish: Hjælp til behandling af overvægt og fedme hos voksne hunde.
English: ATCvet code: QA08AB91
Danish: ATCvet-kode: QA08AB91.
English: Oral dosing devices used for measuring the dose may be cleaned with water but must be dried before re-use.
Danish: Afmålingsudstyr til oral dosering kan vaskes med vand, men skal tørres før brug.
English: Slentrol may cause eye-irritation.
Danish: Slentrol kan forårsage øjenirritation.
English: Slentrol can be administered with or without food.
Danish: Slentrol kan gives med eller uden foder.
English: The veterinarian will advise you when dose adjustments become necessary.
Danish: Dyrlægen vil anvise, hvornår justering af doseringen bliver nødvendig.
English: This is consistent with in vivo data generated in mice which shows that dirlotapide has selectivity for intestinal MTP.
Danish: Dette stemmer overens med in vivo-data fra mus som viser, at dirlotapid viser selektivitet over for intestinalt MTP.
English: Interactions with other drug types have not been specifically investigated.
Danish: Interaktioner med andre stoftyper er ikke undersøgt specifikt.
English: Pharmacotherapeutic group: Peripherally acting antiobesity products.
Danish: Farmakoterapeutisk gruppe: Perifert virkende antiadipositaspræparat.
English: Date of first authorisation: 13/04/2007
Danish: Dato for første markedsføringstilladelse: 13/04/2007 Dato for seneste fornyelse af markedsføringstilladelse: 10/04/2012
English: Special precautions to be taken by the person administering the veterinary medicinal product to dogs: The veterinary medicinal product does not mix with water.
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til hunde: Veterinærlægemidlet er ikke blandbart med vand.
English: AUC and Cmax increased with increasing dose but not in a dose-proportional manner.
Danish: Arealet under kurven (AUC) og Cmax øgedes med stigende dosis, men ikke dosisafhængigt.
English: Polypropylene bottles of 20, 50 and 150 ml fitted with a low density polyethylene (LDPE) Press-In-bottle adapter and a child resistant closure.
Danish: Polypropylenflasker på 20, 50 og 150 ml lukket med en low density polyethylene (LDPE) press-in flaskeadaptor med en børnesikret lukning.
English: Some dogs (less than 10%) experienced repeated vomiting (i.e. more than once every 20 days on average).
Danish: Nogle hunde (mindre end 10 %) kastede op flere gange (dvs. i gennemsnit mere end én gang hver 20. dag).
English: Your veterinary surgeon will identify a target weight and explain how Slentrol should be used as part of an overall weight management programme which also includes appropriate dietary changes and exercise practice.
Danish: Dyrlægen vil fastlægge et mål for vægt og forklare, hvorledes Slentrol bør anvendes som en del af et samlet vægtkontrolprogram, som også omfatter passende kostforandringer og motion.
English: The first time a conditional increase is required, the dose should be increased by 100%, (doubled).
Danish: Den første gang en betinget øgning er nødvendig, skal dosis øges med 100 % (fordobles).
English: The efficacy of dirlotapide has been demonstrated with various types of diets, representing the whole range of fat contents available in commercial diets.
Danish: Dirlotapids virkning er vist med forskellige typer foder, der repræsenterer hele spektret af det fedt, som forekommer i det kommercielle foder.
English: Oral use.
Danish: Oral opløsning.
English: Not applicable (systematic) Dose 2 = Dose 1 x 2
Danish: Ikke aktuelt (systematisk) Dosis 2 = Dosis 1 x 2
English: According to clinical studies, a mean weight loss of about 18 to 20% after six months of weight loss therapy can be anticipated.
Danish: Ifølge kliniske studier kan der forventes et vægttab på omkring 18 til 20 % efter seks måneders slankebehandling.
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please inform
Danish: Hvis De bemærker alvorlige bivirkninger eller andre bivirkninger, som ikke er omtalt i denne indlægsseddel, bedes De kontakte Deres dyrlæge.
English: Advice for Veterinarian:
Danish: Vejledning til dyrlægen:
English: Administer the veterinary medicinal product once daily directly into the mouth or on a small amount of food.
Danish: Giv veterinærlægemidlet én gang dagligt direkte i munden eller i en lille del af foderet.
English: After two weeks of therapy, the initial dose volume should be doubled.
Danish: Efter to ugers behandling bør den indledende dosis fordobles.
English: Dirlotapide exhibited rapid oral absorption with mean Cmax values in the range of 8.5- 115 ng/ml, at 0.5 to 4 hours post-treatment (mean Tmax: 1.0 to 2.1 hours).
Danish: Dirlotapid viste hurtig oral absorption med gennemsnitlige peak-koncentrationer (Cmax-værdier omkring 8,5-115 ng/ml ½-4 timer efter behandling (gennemsnitlig tid til maksimal koncentration (Tmax: 1,0-2,1 timer).
English: At the end of each month of therapy, the percentage of bodyweight loss should be determined.
Danish: Ved slutningen af hver måneds behandling skal det procentvise vægttab beregnes.
English: Systemic blood levels of dirlotapide are not well correlated with efficacy in the dog.
Danish: Dirlotapids systemiske blodniveauer i hunde er ikke korreleret med effekten.
English: In case of excessive weight loss greater than 12% per month, the dose volume of the veterinary medicinal product should be reduced (by 25%).
Danish: I tilfælde af alt for stort vægttab, større end 12 % pr. måned, skal dosisvolumen af veterinærlægemidlet reduceres (med 25 %).
English: As a consequence of reducing intestinal fat absorption, dirlotapide reduces food intake in dogs in a dose-dependent manner.
Danish: Som en konsekvens af reduktionen af den intestinale fedtabsorption reducerer dirlotapid foderindtagelsen hos hunde på en dosisafhængig måde.
English: The inhibition of intestinal and hepatic MTP reduces plasma cholesterol and triglyceride concentration.
Danish: Hæmningen af intestinalt og hepatisk MTP reducerer plasmakolesterol og koncentrationen af triglycerid.
English: These signs typically started during the first month of treatment (about 30% of dogs showed at least one vomiting event and up to 12% showed any of the other signs) and decreased continuously during the course of treatment.
Danish: Disse symptomer startede typisk i løbet af den første måned af behandlingen (omkring 30 % af hundene havde mindst én opkastning og op til 12 % viste et af de andre symptomer) og stilnede af i det fortsatte behandlingsforløb.
English: Do not use in dogs in which overweight or obesity is caused by a concomitant systemic disease such as hypothyroidism or hyperadrenocorticism.
Danish: Må ikke bruges til hunde, hos hvem overvægt eller fedme skyldes samtidig systemisk sygdom som hypothyroidisme eller hyperfunktion af binyrebarken.
English: Clinical and pharmacodynamic data strongly suggest that the efficacy of dirlotapide results from a primary local action in the gut after oral administration.
Danish: Kliniske og farmakodynamiske data tyder på, at dirlotapids effekt kommer fra en primær lokal virkning i tarmen efter oral indgift.
English: EXP {month/year} Once opened, use within 3 months
Danish: EXP {måneder/år} Efter anbrud/åbning anvendes inden 3 måneder
English: NATURE: 20 ml, 50 ml, 150 ml bottle
Danish: 20 ml, 50 ml, 150 ml flaske
English: 3% bodyweight loss per month = 0.7% per week = 0.1% per day The lowest validated dose for the dosing device is 0.05 ml.
Danish: 3 % vægttab pr. måned = 0,7 % pr. uge = 0,1 % pr. dag Den lavest validerede dosering for afmålingsapparaturet er 0,05 ml.
English: Dosing may be recommenced at the same or at a reduced dose volume (reduced by 25%), but if vomiting reoccurs, the veterinary medicinal product may
Danish: Behandlingen kan genoptages med samme eller reduceret dosis (reduceret med 25 %), men hvis opkastninger begynder igen, kan det blive nødvendigt at stoppe behandlingen med veterinærlægemidlet.
English: Withdraw the veterinary medicinal product from the bottle using the supplied dosing device and administer the veterinary medicinal product once daily directly into the mouth or on a small amount of food.
Danish: Træk veterinærlægemidlet ud af flasken ved hjælp af det vedlagte doseringsmål, og giv veterinærlægemidlet én gang daglig enten direkte i munden eller i en lille portion foder.
English: Use in dogs intended for breeding should be subject to a risk-benefit analysis (see section 4.7).
Danish: Anvendelse til hunde, der skal bruges til avl, bør risikovurderes (se pkt.
English: Volume to administer in ml
Danish: Udløser for dosisøgning Dosisvolumen i ml
English: In order to avoid this rebound weight gain, it is necessary to feed the dogs to maintenance energy requirements.
Danish: For at undgå dette tilbagefald, er det nødvendigt at fodre hundene til det der kræves til energivedligeholdelse.
English: Overdose up to 10 times the maximum authorised dose of 1 mg/kg current bodyweight may produce vomiting or diarrhoea or increased ALT/AST (alanine aminotransferase/aspartate aminotransferase) levels.
Danish: Overdosering op til 10 gange den højeste anbefalede dosis på 1 mg/kg af den aktuelle legemsvægt kan forårsage opkastning eller diarré eller forhøjet ALT/AST (alaninaminotransferase/aspartataminotransferase)-niveau.
English: Sporadic and mild serum alanine aminotransferase (ALT) elevations up to 4 times the upper reference range are not a reason for discontinuing therapy in the absence of any indication of liver dysfunction.
Danish: Sporadiske og milde serum-alanin-amino-transferase (ALT) stigninger op til 4 gange den øverste referenceværdi er ikke grund til afbrydelse af behandlingen, hvis der ikke er nogen indikation på leverdysfunktion.
English: 5 (conditional)
Danish: 5 (betinget)
English: Dirlotapide 5 mg/ml is a colourless to pale yellow solution.
Danish: Dirlotapid 5 mg/ml er en farveløs til svagt gul opløsning.
English: This food inhibitory effect of dirlotapide results from a primary local effect on the gastrointestinal tract following oral administration and is not a result of systemic exposure.
Danish: Dirlotapids appetithæmmende virkning stammer fra en primær lokal virkning på mave-tarmkanalen efter oral administration og er ikke resultat af en systemisk påvirkning.
English: The selective inhibition of intestinal MTP also reduces intestinal fat absorption.
Danish: Den selektive hæmning af intestinalt MTP reducerer også absorptionen af fedt fra tarmen.
English: Do not use in cats due to the risk of development of hepatic lipidosis.
Danish: Må ikke anvendes til katte på grund af risiko for udvikling af fedtlever.
English: Because the veterinary medicinal product is contraindicated in cases of liver dysfunction, any indication of progressive liver damage or dysfunction should result in the discontinuation of the treatment.
Danish: Da veterinærlægemidlet er kontraindiceret i tilfælde af leverdysfunktion skal enhver indikation på udvikling af leverskade eller -dysfunktion medføre afbrydelse af behandlingen.
English: Slentrol 5 mg/ml oral solution for dogs
Danish: Slentrol 5 mg/ml oral opløsning til hunde
English: 6 (conditional)
Danish: 6 (betinget)
English: Do not use in dogs with impaired liver function.
Danish: Må ikke bruges til hunde med svækket leverfunktion.
English: To ensure correct dosing during the treatment period the owner should seek advice from the responsible veterinarian in connection to each monthly dose adjustment.
Danish: For at sikre korrekt dosering i behandlingsperioden, bør ejeren rådføre sig med den ansvarlige dyrlæge i forbindelse med den månedlige dosisjustering.
English: Some dogs may show one or more vomiting events, sometimes accompanied by signs of tiredness, disinterest in food or diarrhoea, which reoccur occasionally during the course of treatment.
Danish: Nogle hunde kan have én eller flere opkastninger, somme tider ledsaget af sløvhed, manglende interesse for mad eller diarré.
English: The duration of treatment must not exceed 12 months and the dose must not exceed a maximum of 0.2 ml /kg current bodyweight (1 mg/kg dirlotapide).
Danish: Behandlingsvarigheden må ikke overskride 12 måneder og dosis må ikke overstige 0,2 ml/kg nuværende legemsvægt (1 mg/kg dirlotapid).
English: During treatment, because food intake is reduced as when using a traditional non-medical calorie restriction method, care must be taken to ensure that protein, vitamins, essential fatty acids and minerals supplied by the daily food ration meet minimal recommended requirements in order to ensure a complete and balanced nutritional supply.
Danish: Under behandlingen må man, da foderindtagelsen er reduceret, når der bruges en traditionel ikkemedicinsk lavenergimetode, sikre at protein, vitaminer, essentielle fede syrer og mineraler, som indtages i den daglige foderration indeholder minimum anbefalede behov, for at sikre en komplet og ernæringsmæssigt afbalanceret ernæring.
English: If vomiting, diarrhoea or significantly reduced appetite or excessive weight loss occurs, treatment should be interrupted and the advice of a veterinarian should be sought.
Danish: Hvis opkastning, diarré eller signifikant reduceret appetit eller ekstremt vægttab forekommer, bør behandlingen afbrydes og dyrlægen rådspørges.