FrancophonIA/ELRC3.0 huggingface dataset:
English: It is important that you do not allow any other dogs or pets you may have to lick or come into contact with the area between your dog's shoulder blades where your veterinarian has applied Recuvyra for at least 3 days (72 hours) following treatment, as this might cause adverse reactions in these animals.
Danish: Det er vigtigt, at du ikke lader nogen anden hund eller noget andet kæledyr slikke eller komme i kontakt med området mellem din hunds skulderblade, hvor din dyrlæge har påført Recuvyra i mindst 3 dage (72 timer) efter behandlingen, da dette kan forårsage bivirkninger i disse dyr.
English: • Vomiting and diarrhoea.
Danish: • Opkastninger og diarré.
English: To address the safety concerns remaining in relation to the novel type of product, and the uncertainty about possible interactions of concomitantly used products during the operation and in the postoperative period, the marketing authorisation holder should arrange for collation and assessment of detailed data on the clinical safety of the product in a representative sample of dogs.
Danish: For at adressere tilbageblevne sikkerhedsspørgsmål hvad angår den nye type produkt, og usikkerheden om mulige interaktioner af samtidigt anvendte produkter under operationen og i den post-operative periode, skal indehaveren af markedsføringstilladelsen arrangere indsamling og vurdering af detaljerede data om den kliniske sikkerhed af produktet fra en repræsentativ prøvestørrelse af hunde.
English: If your dog is more than mildly sedated, or has decreased appetite or water intake, you should contact your veterinary surgeon for advice.
Danish: Hvis din hund er mere end mildt sederet eller har nedsat appetit eller vandindtagelse, skal du kontakte din dyrlæge for at få rådgivning.
English: At the moment of drying, approximately 2 to 5 minutes after application, fentanyl and octyl salicylate are absorbed into the stratum corneum.
Danish: På tørringstidspunktet, ca. 2 til 5 minutter efter applikationen, absorberes fentanyl og octylsalicylat i stratum corneum.
English: You should tell your veterinarian if you know any of these applies about your dog before treatment is given.
Danish: Du bør fortælle din dyrlæge, hvis du ved, at dette forholder sig sådan med din hund før behandlingen startes.
English: It may be necessary to evacuate air from the syringe back into the vial.
Danish: Det kan være nødvendigt at tømme luft fra sprøjten tilbage i hætteglasset.
English: The tissues should be discarded immediately following use.
Danish: Servietterne skal bortskaffes umiddelbart efter brug.
English: Recuvyra should not be used if your dog is pregnant, lactating or is used for breeding, or if your dog is less than 6 months old.
Danish: Recuvyra bør ikke anvendes til din hund, hvis den er drægtig, diegivende eller anvendes til avl eller hvis din hund er yngre end 6 måneder gammel.
English: The vial must be placed upright on a firm, stable surface during placement and application of the adaptor.
Danish: Hætteglasset skal anbringes opretstående på en fast, stabil flade under anbringelse og applikation af adapteren.
English: If the volume to be administered is greater than 0.5 ml, move the applicator tip at least 2.5 cm from the initial site and apply up to 0.5 ml.
Danish: Hvis mængden, der skal indgives, er større end 0,5 ml, flyttes applikatorspidsen mindst 2,5 cm fra det første sted og der anvendes op til 0,5 ml.
English: Shelf life after first broaching the vial: 30 days.
Danish: Opbevaringstid efter første åbning af hætteglasset: 30 dage.
English: However, in dogs with thick hair coats, it is advisable to clip the hair prior to application to assure direct contact of the veterinary medicinal product with the skin.
Danish: Hos hunde og katte med tykke pelse, tilrådes det imidlertid at fjerne håret før applikation for at sikre direkte kontakt af veterinærlægemidlet med huden.
English: The analgesic effects of the veterinary medicinal product are related to the resulting fentanyl blood concentration achieved following application.
Danish: Veterinærlægemidlets analgesiske virkning er forbundet til den resulterende fentanylblodkoncentration, der blev opnået efter applikation.
English: Do not store or use near a naked flame.
Danish: Må ikke opbevares eller anvendes nær en åben flamme.
English: Restrain the dog for approximately 2 minutes and avoid contact with the application site for 5 minutes to allow complete drying of the solution.
Danish: Hold hunden i ca. 2 minutter og undgå kontakt med applikationsstedet i 5 minutter, således at opløsningen er blevet fuldstændig tør.
English: Your veterinarian should not administer Recuvyra:
Danish: Din dyrlæge bør ikke indgive Recuvyra:
English: As a class, opioids, including this veterinary medicinal product, may cause low body temperature, slow respiratory rate, low blood pressure or slow heart rate.
Danish: Som klasse kan opioider, herunder dette veterinære lægemiddel, forårsage lav kropstemperatur, langsom vejrtrækning, lavt blodtryk eller langsomme hjerteslag.
English: The effects of the concomitant use of the veterinary medicinal product and α-adrenergic agonists have not been studied.
Danish: Virkningerne af samtidig anvendelse af veterinærlægemidlet og α-adrenerge agonister er ikke blevet undersøgt.
English: The most common symptoms associated with fentanyl overdose in people include respiratory depression, sedation and myosis.
Danish: De mest almindelige symptomer forbundet med en fentanyloverdosis hos mennesker, omfatter respiratorisk depression, sedation og myose.
English: Appropriate eye lubrication should therefore be applied prior to and following surgery and continued until the dog resumes normal blinking function.
Danish: Der skal derfor foretages relevant smøring af øjne før og under operationen, som skal fortsættes, indtil hunden genoptager sin normale blinkefunktion.
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Danish: Hvis du vil have yderligere oplysninger om veterinærlægemidlet, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: Personal protective equipment consisting of latex or nitrile gloves, eye protection and suitable protective clothing should be worn when handling this veterinary medicinal product.
Danish: Der skal bæres personligt beskyttelsesudstyr, der består af latex- eller nitrilhandsker, øjenbeskyttelse og egnet beskyttelsestøj, når dette veterinære lægemiddel håndteres.
English: Clear, colourless to light yellow solution.
Danish: Klar, farveløs til svagt gul opløsning.
English: Following application to dogs, do not touch the site for 5 minutes.
Danish: Efter applikation til hunden, må stedet ikke berøres i 5 minutter.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (EMEA) http://www.emea.europa.eu/.
English: The veterinary medicinal product should not be used in animals with systemic illness.
Danish: Veterinærlægemidlet bør ikke anvendes til dyr med systemiske lidelser.
English: Vomiting and diarrhoea are also common adverse reactions.
Danish: Opkastninger og diarré er også almindelige bivirkninger.
English: However, for small children (15 kg) such contact might still result in serious exposure to fentanyl.
Danish: For små børn (15 kg) kan en sådan kontakt stadig resultere i alvorlig eksponering over for fentanyl.
English: Apply up to 0.5 ml onto the skin without moving the applicator tip.
Danish: Anvend op til 0,5 ml på huden uden at flytte applikatorspidsen.
English: Mild side effects such as sedation, may occur after a single accidental oral administration of more than 20 µg/kg of fentanyl (0.4 µl/kg Recuvyra).
Danish: Milde bivirkninger, såsom sedation, kan forekomme efter en enkelt utilsigtet, oral indgivelse af mere end 20 µg/kg fentanyl (0,4 µl/kg Recuvyra).
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Danish: TEKSTEN “KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: The clearance of fentanyl ranges from 1.7 to 4.7 l/h/kg in dogs.
Danish: Fentanyls clearance ligger fra 1,7 til 4,7 l/t/kg hos hunde.
English: Children should not touch the dog before: Date
Danish: Børn kan røre hunden fra: Dato
English: • A 3 ml polypropylene syringe with a silicone O-ring fitted to the plunger.
Danish: • En 3 ml polypropylensprøjte med O-ring af silikone, der er tilpasset stemplet.
English: Thoroughly clean any contaminated clothing before reuse.
Danish: Eventuelt kontamineret tøj rengøres grundigt før det bruges igen.
English: This depression may be reversed by use of a suitable reversal agent, such as naloxone.
Danish: Denne depression kan reverseres vha. et egnet reverseringsmiddel, såsom naloxon.
English: Once Recuvyra has been administered, your veterinarian will carefully monitor your dog to ensure it responds safely to the product.
Danish: Når Recuvyra er blevet indgivet, vil din dyrlæge nøje overvåge din hund for at sikre, at den reagerer sikkert på produktet.
English: Do not allow the dog or other animals to lick the site of application as oral bioavailability following licking is high in the first five minutes after application.
Danish: Hunden eller andre dyr må ikke slikke applikationsstedet, da den orale biotilgængelighed efter at have slikket på det er høj i de første fem minutter efter applikation.
English: Very commonly (i.e. in more than 10% of treated dogs)
Danish: Meget almindeligt (dvs. hos mere end 10 % af behandlede hunde)
English: Therefore, dogs should be continuously monitored for rectal temperature, pulse rate, respiratory rate and heart rhythm during surgical anaesthesia.
Danish: Derfor skal hunde overvåges kontinuerligt for rektal temperatur, pulsfrekvens, vejrtrækningshastighed og hjerterytme under kirurgisk anæstesi.
English: Remove the plastic protective cover from the top of the glass vial.
Danish: Fjern beskyttelseshætten af plastik fra hætteglasset.
English: Terminal half-life (hrs)
Danish: Terminal halveringstid (timer)
English: Higher oral doses may induce anaesthetic effects and cardiopulmonary depression.
Danish: Højere orale doser kan fremkalde anæstetiske virkninger og kardiopulmonal depression.
English: It is imperative that the veterinary medicinal product is not applied to any other site on the body than the dorsal scapular area, as absorption has been shown to vary between different locations of skin.
Danish: Det er vigtigt, at veterinærlægemidlet ikke anvendes på noget andet sted på kroppen end skulderbladsregionen, da det er blevet påvist, at absorption varierer på forskellige steder på huden.
English: Fentanyl exerts its analgesic action by binding to and activating µ (mu) opioid receptors that are predominantly found in the pain regulating areas of the brain and spinal cord.
Danish: Fentanyl anvender sin analgesiske virkning ved at binde sig til og aktivere µ (mu) opioide receptorer, der hovedsageligt findes i hjernens og rygsøjlens smerteregulerende områder.
English: If a small child touches the application site within 72 hours of application, the child's skin that touched the dog (for example, fingers) should not contact the child's mouth, and the skin should be washed with soap and water.
Danish: Hvis et lille barn rører applikationsstedet inden for 72 timer fra applikationen, bør barnets hud, der rørte ved hunden (for eksempel fingrene), ikke komme i kontakt med barnets mund, og huden bør vaskes med vand og sæbe.
English: Fentanyl is a potent anaesthetic sparing substance.
Danish: Fentanyl er et kraftigt anæstetikabesparende stof.
English: In field trials, 2 % of dogs treated with the veterinary medicinal product required reversal of adverse opiate effects with naloxone.
Danish: I forsøg var det nødvendigt for 2 % af hunde, der blev behandlet med veterinærlægemidlet at reversere utilsigtede opiatvirkninger med naloxon.
English: The use of syringes not supplied with this veterinary medicinal product, or storage of this veterinary medicinal product in a syringe may lead to dosing inaccuracy.
Danish: Anvendelsen af sprøjter, der ikke er vedlagt dette veterinære lægemiddel, eller opbevaring af dette veterinære lægemiddel i en sprøjte, kan resultere i unøjagtig dosering.
English: A single dose relieves pain for at least 4 days.
Danish: En enkelt dosis lindrer smerter i mindst 4 dage.
English: The effects of transdermal fentanyl could last longer than the effects of the opioid reversal agent.
Danish: Virkningerne af transdermal fentanyl kan vare længere end virkningerne af en modgift mod opioider.
English: • A polycarbonate Robertsite vial adaptor (allowing needleless luer connection to the vial).
Danish: • En Robertsite polycarbonat hætteglasadapter (der muliggør en nåleløs luerforbindelse med hætteglasset).
English: The application site should be clean and free of any surface matter.
Danish: Applikationsstedet skal være rent og frit for overfladepartikler.
English: To help you remember when your dog was given Recuvyra by your veterinarian and how long you should not let children touch your dog in the place where the product was applied, your veterinarian will make a note in the spaces provided below.
Danish: For at hjælpe dig med at huske, hvornår din hund fik Recuvyra af din dyrlæge og hvor længe dine børn ikke bør røre hunden på stedet, hvor produktet blev påført, vil din dyrlæge udfylde nedenstående felter.
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Danish: FREMSTILLERENS BATCHNUMMER Lotnummer
English: The safety of the veterinary medicinal product in animals less than 6 months of age has not been established.
Danish: Veterinærlægemidlets sikkerhed hos dyr, der er under 6 måneder gamle, er ukendt.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For transdermal use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Til transdermal anvendelse.
English: Attaching adaptor (see Figure 1):
Danish: Tilslutning af adapter (se Figur 1):
English: Commonly (i.e. in 1 to 10% of treated dogs)
Danish: Almindeligt (dvs. hos 1 til 10 % af behandlede hunde)
English: • A 2-pronged polycarbonate applicator tip.
Danish: • En 2-grenet applikatorspids af polycarbonat.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Octyl salicylate
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Fortegnelse over hjælpestoffer Octylsalicylat
English: If symptoms develop following exposure to the veterinary medicinal product such as erythema, confusion, nausea or vomiting, medical advice should be sought immediately.
Danish: Hvis der udvikler sig symptomer efter eksponering over for veterinærlægemidlet såsom erythem, forvirring, kvalme eller opkastninger, skal der søges medicinsk hjælp øjeblikkeligt.
English: Banbury, Oxfordshire, OX16 4RS United Kingdom.
Danish: Banbury, Oxfordshire, OX16 4RS Storbritannien.
English: Only up to 0.5 ml can be applied to one area of skin.
Danish: Der kan kun anvendes op til 0,5 ml på ét hudområde.
English: Therefore, α2-adrenergic agonists should be used with caution in animals dosed with the veterinary medicinal product due to potentially additive or synergistic effects.
Danish: Der for skal α2-adrenerge agonister anvendes med forsigtighed hos dyr, der er doseret med veterinærlægemidlet pga. mulige additive eller synergistiske virkninger.
English: The above side effects can occur up to 3 days (72 hours) after Recuvyra was given to your dog.
Danish: Ovennævnte bivirkninger kan opstå op til 3 dage (72 timer) efter, at Recuvyra blev givet til din hund.
English: In rare cases, dysphoria and urinary retention have also been observed.
Danish: I sjældne tilfælde er der observeret dysfori og urinrentention.
English: Eli Lilly Benelux Stoofstraat 52
Danish: Luxembourg/Luxemburg Eli Lilly Benelux Stoofstraat 52
English: Gastrointestinal stasis can result in serious complications and consideration should be given to opiate reversal in case of excessive narcosis (see section 4.10).
Danish: Gastrointestinal stase kan resultere i alvorlige komplikationer og en opiatomgørelse skal overvejes i tilfælde af kraftig narkose (se pkt.
English: If a child orally contacts the application site within 72 hours of application, medical attention should be sought immediately.
Danish: Hvis et barn kommer i kontakt med applikationsstedet med munden inden for 72 timer efter applikationen, skal der straks søges lægehjælp.
English: 1 vial (10 ml) 1 vial adaptor 15 syringes 15 applicator tips
Danish: 1 hætteglas (10 ml) 1 hætteglasadapter 15 sprøjter 15 applikatorspidser
English: Severe overdose may result in renal failure secondary to hypotension produced by gastrointestinal hypomobility.
Danish: En alvorlig overdosis kan resultere i nyresvigt efter hypotension, der er forårsaget af gastrointestinal hypomobilitet.
English: Blot up any noticeable solution using an absorbent material such as paper tissues.
Danish: Synlig opløsning duppes op med absorberende materiale, såsom papirservietter.
English: Only use the syringes provided.
Danish: Anvend kun de vedlagte sprøjter.
English: Fentanyl very commonly causes dose-dependent sedation in dogs which is associated with potential decreased food and water intake, decreased stool production and transient weight loss.
Danish: Fentanyl forårsager meget almindeligt dosisafhængig sedation hos hunde, som er forbundet med mulig nedsat mad- og vandindtagelse, nedsat afføring og forbigående vægttab.
English: 50 mg/ml For a full list of excipients, see section 6.1.
Danish: 50 mg/ml Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: • Lowering of heart and breathing rates.
Danish: • Nedsættelse af hjerte- og vejrtrækningshastigheder.
English: • Has heart failure, low or high blood pressure, low blood volume, impaired breathing, has a history of epilepsy, non-aged related corneal pathology or has or might have a partial or completely stationary bowel.
Danish: • Har hjertesvigt, lavt eller forhøjet blodtryk, lav blodmængde, svækket åndedræt, har en sygdomshistorie med epilepsi, ikke-alders relateret corneapatologi eller har eller kan have delvis eller hel forstoppelse.
English: The use of the veterinary medicinal product may result in corneal drying during prolonged sedation.
Danish: Anvendelsen af veterinærlægemidlet kan resultere i udtørring af cornea under langvarig sedation.
English: Do not give more than the recommended dose of the veterinary medicinal product.
Danish: Der må ikke gives mere end den anbefalede dosis af veterinærlægemidlet.
English: Dogs must not be discharged to owners until post-operative sedation is mild or absent and dogs are drinking water and eating voluntarily at an appropriate level for the condition that required surgery.
Danish: Hunde må ikke udskrives til deres ejere, før postoperativ sedation er mild eller fraværende og hundene drikker vand og spiser frivilligt på et passende niveau for den tilstand, der var årsagen til operationen.
English: The use of the veterinary medicinal product is intended as a single application administered 2 to 4 hours prior to surgery to provide analgesia for at least 4 days.
Danish: Anvendelsen af veterinærlægemidlet er beregnet til en enkelt applikation indgivet 2 til 4 timer før en operation for at opnå analgesi i mindst 4 dage.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Recuvyra is a clear, colourless to light yellow solution containing 50 mg of fentanyl (the active substance) per ml of solution.
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Recuvyra er en klar, farveløs til let gul opløsning, der indeholder 50 mg fentanyl (det aktive stof) pr. ml opløsning.
English: Accumulation of fentanyl following repeated administration could result in severe adverse reactions, including death.
Danish: Ophobning af fentanyl efter gentagen anvendelse kan resultere i alvorlige bivirkninger, herunder død.
English: However, for children such contact might still result in serious exposure to fentanyl.
Danish: For børn kan en sådan kontakt imidlertid stadig resultere i alvorlig eksponering over for fentanyl.
English: Fentanyl gradually moves through the skin into your dog's bloodstream and then relieves pain.
Danish: Fentanyl bevæger sig gradvist gennem huden og ind i din hunds blodstrøm og virker dernæst smertestillende.
English: Plasma fentanyl concentrations reach 1.0 ng/ml, (which is generally considered analgesic) in more than 60% of dogs within 4 hours of administration.
Danish: Plasmafentanylkoncentrationer når 1,0 ng/ml (som generelt betragtes som analgesisk) hos mere end 60 % hunde inden for 4 timer efter indgivelse.
English: The veterinary medicinal product should be administered with caution.
Danish: Veterinærlægemidlet skal indgives med forsigtighed.
English: Rua Galileu Galilei, Nº2 Piso 7 Fracção A/D 1500 - 392 LISBOA
Danish: Rua Galileu Galilei, Nº2 Piso 7 Fracção A/D
English: For the attention of dog owner
Danish: Til hundeejeren
English: The recommended dose is 2.6 mg fentanyl/kg bodyweight (i.e. 0.052 ml/kg bw), applied topically to the dorsal scapular area 2 to 4 hours prior to surgery and according to the dosing table below.
Danish: Den anbefalede dosis er 2,6 mg fentanyl/kg kropsvægt (dvs. 0,052 ml/kg kropsvægt), anvendt topisk i skulderbladsregionen 2 til 4 timer før operation og i henhold til doseringstabellen nedenfor.
English: Fentanyl partitions from the stratum corneum through the deeper skin layers and into the systemic circulation over a period of days.
Danish: Fentanyl opdeler sig fra stratum corneum gennem de dybere hudlag og ind i det systemiske kredsløb i løbet af nogle dage.
English: BATCH NUMBER Lot {number}
Danish: BATCHNUMMER Lotnummer
English: Do not give a second dose of the veterinary medicinal product within 7 days.
Danish: Der må ikke gives mere end én dosis af veterinærlægemidlet inden for 7 dage.
English: ANNEX II A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE D. STATEMENT OF THE MRLs
Danish: BILAG II A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN, HERUNDER BEGRÆNSNINGER FOR UDLEVERING OG BRUG C. FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG D. ANGIVELSE AF MRL-VÆRDIER
English: • Has an allergy to the active substance (fentanyl) or to any of the excipients.
Danish: • Har en overfølsomhed over for det aktive stof (fentanyl) eller over for et eller flere af hjælpestofferne.
English: Attaching the adaptor
Danish: Tilslutning af adapteren
English: Place applicator tip at an approximate 45º angle directly onto the skin in the dorsal scapular region.
Danish: Anbring applikatorspidsen i ca. en 45º vinkel direkte på huden i skulderbladsregionen.
English: SMALL CHILDREN SHOULD NOT TOUCH THE DOG FOR 72 HOURS (3 days) AFTER RECUVYRA IS APPLIED TO THE DOG.
Danish: SMÅ BØRN BØR IKKE RØRE HUNDEN I 72 TIMER (3 DAGE) EFTER, AT RECUVYRA ER BLEVET GIVET TIL HUNDEN.
English: When using Recuvyra your veterinarian should use less anaesthetic agents and administer them only to achieve the desired effect.
Danish: Når din dyrlæge anvender Recuvyra skal han/hun anvende mindre anæstetika og kun indgive dem for at opnå den ønskede virkning.
English: Application of Recuvyra will not cause your dog any pain and your veterinarian will use a dosing table and a specially designed applicator to carefully apply the product onto the skin surface without using any needles.
Danish: Anvendelse af Recuvyra vil ikke foranledige nogen smerter for din hund og din dyrlæge vil anvende en doseringstabel og en særligt designet applikator til nøje at påføre produktet på hudens overflade uden brug af nåle.
English: Dispose of the used syringe/applicator tip as a unit in an appropriate container.
Danish: Bortskaf den anvendte sprøjte/applikatorspids som en enhed i en dertil beregnet beholder.