FrancophonIA/ELRC3.0 huggingface dataset:
English: The effects of the medicine were first tested in experimental models before being studied in humans.
Danish: Virkningerne af lægemidlet er først testet i forsøgsmodeller, inden de er undersøgt hos mennesker.
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.eu.int http://www.emea.eu.int EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Danish: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.eu.int http://www.emea.eu.int
English: The CHMP takes up to 210 days to evaluate an application for an extension of a marketing authorisation.
Danish: CHMP bruger indtil 210 dage på at vurdere en ansøgning om udvidelse af en markedsføringstilladelse.
English: Following CHMP opinion, it usually takes around 2 months for the European Commission to update a licence.
Danish: Efter at CHMP har afgivet sin udtalelse, er Europa-Kommissionen sædvanligvis ca. to måneder om at ajourføre tilladelsen.
English: International Non-proprietary Name (INN): Olopatadine hydrochloride
Danish: Internationalt fællesnavn (INN): Olopatadinhydrochlorid
English: What were the reasons given by the company for withdrawing the application?
Danish: Hvilke grunde angav firmaet for tilbagetrækningen af ansøgningen?
English: The CHMP had formulated a list of questions to be answered by the Company, and the Company had not yet responded to them.
Danish: CHMP havde opstillet en række spørgsmål, som firmaet skulle besvare, hvilket endnu ikke var sket.
English: Olopatadine, the active substance in Opatanol, is an antihistaminic.
Danish: Olopatadin, det aktive stof i Opatanol, er et antihistamin.
English: This means that it blocks the action of histamine, a natural substance in the body that is released when the body is exposed to an allergen.
Danish: Det betyder, at det blokerer virkningen af histamin, et stof, der naturligt frigøres i organismen ved udsættelse for et allergifremkaldende stof.
English: EMEA/60142/2006
Danish: London, den 23. februar 2006 Ref. EMEA/60142/2006
English: What documentation was presented by the Company to support the application to the CHMP?
Danish: Hvilken dokumentation har firmaet fremlagt i forbindelse med ansøgningen til CHMP?
English: On 14 February 2006, Alcon Laboratories (U.K.) Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for an extension of the marketing authorisation for Opatanol, to add a new pharmaceutical form, a nasal spray intended for a new use in the treatment of the signs and symptoms of seasonal and perennial rhinitis.
Danish: Den 14. februar 2006 meddelte Alcon Laboratories (U.K.) Limited officielt til Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønskede at trække sin ansøgning tilbage om udvidelse af markedsføringstilladelsen for Opatanol for en ny lægemiddelform, en næsespray til den nye anvendelse behandling af symptomerne ved høfeber og tilbagevendende snue.
English: Opatanol nasal spray is a solution containing 6 mg/ml of the active substance, olopatadine (as the hydrochloride).
Danish: Opatanol næsespray er en opløsning indeholdende 6 mg/ml af det aktive stof, olopatadin (som hydrochlorid).
English: What is happening with regard to Opatanol eye drops used for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis?
Danish: Hvad sker der med Opatanol øjendråber, der anvendes til behandling af symptomer på sæsonbundet allergisk conjunctivitis?
English: Based on the currently available data, the CHMP has no concern regarding the use of Opatanol eye drops.
Danish: De aktuelt foreliggende oplysninger giver ikke CHMP anledning til betænkelighed ved brugen af Opatanol øjendråber.
English: Opatanol has been authorised in the European Union since 17 May 2002 as eye drops for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.
Danish: Opatanol har været godkendt i EU siden den 17. maj 2002 som øjendråber til behandling af symptomer fra øjnene på sæsonbundet allergisk conjunctivitis (øjenbetændelse).
English: Once the Company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions (at day 180) to be answered by the Company in writing or during a hearing.
Danish: Når firmaet har besvaret spørgsmålene, gennemgår CHMP besvarelsen og kan, inden det afgiver en udtalelse, stille eventuelle supplerende spørgsmål (på dag 180) til firmaet.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Opatanol?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser af Opatanol eller i programmer for anvendelse med særlig udleveringstilladelse?
English: The studies in hay fever lasted two weeks and looked at how the symptoms were improved.
Danish: Undersøgelserne af høfeber varede to uger, og her registreredes bedringen i symptomerne.
English: There are no ongoing clinical trials or compassionate use programmes with Opatanol nasal spray in the EU.
Danish: Der er ingen igangværende kliniske undersøgelser af Opatanol næsespray eller programmer for anvendelse med særlig udleveringstilladelse i EU.
English: Opatanol nasal spray was to be used to treat the signs and symptoms of allergic conditions of the nose, rhinitis (sneezing, itchy nose, runny nose and congestion), due to some materials (allergens) from pollens, house dust or animals.
Danish: Opatanol næsespray var beregnet til behandling af allergiske symptomer fra næsen (nysen og kløende, løbende og tæt næse) forårsaget af visse allergifremkaldende stoffer fra pollen, husstøv eller dyr.
English: The study in perennial rhinitis lasted one year.
Danish: Undersøgelsen af tilbagevendende snue varede et år.
English: What was Opatanol nasal spray expected to be used for?
Danish: Hvad forventedes Opatanol næsespray anvendt til?
English: The CHMP wanted to see the effect of Opatanol nasal spray compared to other medicines for the treatment of hay fever and perennial rhinitis.
Danish: CHMP ønskede at se virkningen af Opatanol næsespray sammenlignet med andre lægemidler til behandling af høfeber og tilbagevendende snue.
English: How is Opatanol nasal spray expected to work?
Danish: Hvordan forventes Opatanol næsespray at virke?
English: The Company submitted the results of clinical studies where Opatanol nasal spray used twice a day was compared to a placebo (a dummy treatment) in the treatment of allergic seasonal rhinitis (hay fever) and in perennial rhinitis.
Danish: Firmaet indsendte resultaterne af de kliniske undersøgelser, hvor Opatanol næsespray, anvendt to gange dagligt, blev sammenlignet med placebo (virkningsløs behandling) til behandling af høfeber og tilbagevendende snue.
English: What is Opatanol nasal spray
Danish: Hvad er Opatanol næsespray?
English: In addition, the CHMP wanted to see the results of further tests carried out by the company to clarify the potential for harm of impurities contained in Opatanol nasal spray before making its recommendation.
Danish: Inden CHMP fremsatte sin anbefaling, ønskede udvalget desuden at se resultaterne af yderligere undersøgelser, som firmaet skulle udføre for at klarlægge risikoen for skadelig virkning af de urenheder, der findes i Opatanol næsespray.
English: The CHMP had concerns and was of the provisional opinion that Opatanol nasal spray could not be approved, for the treatment of the signs and symptoms of seasonal and perennial rhinitis.
Danish: CHMP fandt grund til betænkelighed, og udvalgets foreløbige standpunkt var, at Opatanol næsespray ikke kunne godkendes til behandling af symptomerne på høfeber og tilbagevendende snue.
English: By blocking the action of histamine, Opatanol nasal spray was expected to help to control the signs and symptoms of allergic rhinitis.
Danish: Ved at blokere virkningen af histamin forventedes Opatanol næsespray at begrænse symptomerne på høfeber.
English: {Alu-PVC/Blisters}
Danish: {Alu-PVC/blister}
English: Do not increase or double the dose.
Danish: Du må ikke øge eller fordoble dosis.
English: Your veterinarian will advise you if this is the case for your dog.
Danish: Din dyrlæge vil rådgive dig, hvis dette er tilfældet for din hund.
English: Toceranib is highly protein bound at between 91% and 93%.
Danish: Toceranib er stærkt proteinbundet, mellem 91% og 93%.
English: See sections 4.4, 4.5 and 4.9 for Dose Adjustment Guidelines.
Danish: 4.4, 4.5 og 4.9 vedrørende vejledning for dosisjustering.
English: Mild to moderate:
Danish: Let til moderat:
English: Tablets are available in three different strengths.
Danish: Tabletterne findes i tre forskellige styrker.
English: • Children should not come in contact with Palladia.
Danish: • Børn bør ikke komme i kontakt med Palladia.
English: Some dogs may also show a loss of colour around their nose, some dogs may show a change in coat colour which appears to lighten and some dogs may lose hair.
Danish: Nogle hunde kan også udvise tab af farve omkring næsen, nogle hunde kan udvise ændring i pelsfarve, som fremstår lysere, og nogle hunde kan tabe pelsen.
English: ≤1000/ul or neutropenic fever or infection
Danish: ≤1000/ µl eller neutropenisk feber eller infektion
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23/09/2009
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 23/09/2009
English: Dogs should be carefully monitored.
Danish: Hundene bør overvåges omhyggeligt.
English: It is not known to what extent toceranib could affect the elimination of other drugs.
Danish: Det vides ikke, i hvilken udstrækning toceranib kan påvirke andre stoffers elimination.
English: Your veterinarian may need to take blood and urine samples from your dog to perform these checks.
Danish: Det kan være nødvendigt, at dyrlægen tager blod- og urinprøver af din hund for at foretage disse kontroller.
English: • Anyone in your household who administers Palladia to your dog should always wash their hands after handling the tablets.
Danish: • Alle i din husstand, som giver Palladia til din hund, bør altid vaske deres hænder efter håndtering af tabletterne.
English: No interaction studies have been performed with toceranib.
Danish: Der er ikke udført interaktionsstudier med toceranib.
English: • If Palladia is accidentally ingested (swallowed or eaten) by you or a family member, seek medical advice immediately.
Danish: • Hvis Palladia indtages ved et uheld (sluges eller spises) af dig eller et familiemedlem, skal du omgående søge lægehjælp.
English: Children must not come into contact with the product.
Danish: Børn må ikke komme i kontakt med lægemidlet.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton after “EXP”.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på ydre emballage efter ”EXP”.
English: Each tablet is marked with the strength (10, 15 or 50) on one side, the reverse side is blank.
Danish: Hver tablet er mærket med styrken (10, 15 eller 50) på den ene side og umærket på den anden side.
English: There are some medicines that you should not give to your dog during treatment because together, they might cause serious adverse effects.
Danish: Der er nogle typer medicin, som du ikke bør give til din hund under behandlingen, da de sammen kan give alvorlige bivirkninger.
English: <50% food intake ≥2 days
Danish: <50% fødeindtagelse ≥2 dage
English: No gender differences in pharmacokinetics were observed in-vivo.
Danish: Der blev ikke observeret kønsforskelle i farmakokinetikken in vivo.
English: If the Palladia tablet is “hidden” in food, make sure that your dog has eaten the entire dose.
Danish: √ Hvis Palladia-tabletten er ”gemt” i foder, skal du sikre at din hund har spist hele dosis.
English: Before performing surgery, discontinue treatment for at least 3 days in order to assure vasculature homeostasis.
Danish: Før operation afbrydes behandling i minimum 3 dage for at sikre vaskulær homeostase.
English: If a dose is missed, the next schedule dose should be given as prescribed.
Danish: Hvis en dosis glemmes, skal den næste planlagte dosis gives som foreskrevet.
English: Or if your dog experiences other changes that concern you
Danish: √ Eller hvis din hund har andre forandringer, der bekymrer dig.
English: Dog Bodyweight (kg)
Danish: Hundens legemsvægt (kg)
English: Tablets can be administered with or without food.
Danish: Tabletterne kan administreres sammen med eller uden foder.
English: The other dog died following gastric perforation.
Danish: Den anden hund døde efter gastrisk perforation.
English: Each blister contains 5 tablets.
Danish: Hver blister indeholder 5 tabletter.
English: After 6 weeks of treatment, a complete response was noted for 8.1 % and partial response was noted for 29.1 % of dogs treated with Palladia.
Danish: Efter 6 ugers behandling blev der observeret en komplet responsrate på 8,1% og et partielt respons på 29,1% for hunde, der blev behandlet med Palladia.
English: Dose adjustment/reduction:
Danish: Dosisjustering/dosisreduktion:
English: Pregnancy, lactation and fertility:
Danish: Drægtighed, laktation og fertilitet:
English: Dogs should be carefully observed following administration to ensure that each tablet is swallowed.
Danish: Hunde bør nøje observeres efter indgivelsen for at sikre, at hver tablet er blevet slugt.
English: Severe:
Danish: Alvorlig:
English: C. STATEMENT OF THE MRLs Not applicable.
Danish: C. ANGIVELSE AF MRL-VÆRDIER Ikke relevant
English: Median TTP for Palladia treated dogs was 9 to 10 weeks and for placebo treated dogs it was 3 weeks.
Danish: Median TTP for Palladia-behandlede hunde var 9 til 10 uger og for placebobehandlede hunde 3 uger.
English: Special information for the veterinarian
Danish: Særlig information til dyrlægen
English: Hypoalbuminemia (albumin) Albumin <1.5 g/dl
Danish: Hypoalbuminæmi (albumin) Albumin <1,5 g/dl
English: • Hematocrit >25%
Danish: • Hæmatokrit >25%
English: There are no in vivo data on the hepatic metabolism in dogs.
Danish: Der foreligger ingen in vivo data vedrørende hepatisk metabolisme hos hunde.
English: This will reduce the risk for children or other household members to accidentally come into contact with Palladia.
Danish: Dette vil nedsætte muligheden for, at børn eller andre familiemedlemmer kommer i kontakt med Palladia.
English: Date of last renewal: 31/07/2014
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 31/07/2014
English: The number of tablets given to your dog may be adjusted by your veterinarian to manage side effects.
Danish: Antallet af tabletter, som gives til hunden, justeres af din dyrlæge for at kontrollere bivirkninger.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Til oral anvendelse.
English: Number of Tablets
Danish: Antal tabletter
English: Ingestion of Palladia may be harmful for children.
Danish: Indtagelse af Palladia kan være skadeligt for børn.
English: The blister should always be returned to the cardboard carton once a tablet or tablets have been removed.
Danish: √ Blisterpakningen bør altid lægges tilbage i æsken, når en tablet eller tabletter er taget ud.
English: The dose should not be <2.2 mg/kg.
Danish: Dosis bør ikke være <2,2 mg/kg.
English: • Creatinine <2.5 mg/dl
Danish: • Kreatinin <2,5 mg/dl
English: Palladia has been associated with diarrhoea or gastrointestinal bleeding which may be severe and requires prompt treatment.
Danish: Palladia har været associeret med diarré eller gastrointestinal blødning, som kan være alvorlig og kræve omgående behandling.
English: The field study comprised a 6-week double-blind placebo controlled phase followed by an un-blinded phase where all dogs received Palladia for a mean duration of 144 days.
Danish: Feltstudiet omfattede en 6-ugers dobbeltblind placebokontrolleret fase efterfulgt af en ikke-blindet fase, hvor alle hunde fik Palladia i gennemsnitligt 144 dage.
English: Palladia tablets should be given to your dog immediately after they are removed from the blister and should not be left around where they could be handled/swallowed by children.
Danish: √ Palladia-tabletterne bør gives til din hund umiddelbart efter, de er taget ud af blisterpakningen og bør ikke efterlades, hvor de kan håndteres/sluges af børn.
English: Tell your veterinarian about all medicines, including overthe-counter products, that you intend to administer to your dog.
Danish: Fortæl din dyrlæge om al medicin, herunder medicin uden recept, som du har tænkt dig at give til din hund.
English: Palladia are round tablets and have a coloured film coat to minimise risk of exposure and to help identify the correct tablet strength.
Danish: Palladia er runde tabletter, der har et farvet filmovertræk for at minimere risikoen for kontakt med lægemiddelstoffet og for at kunne identificere den korrekte tabletstyrke.
English: Dose Adjustment Based on Clinical Signs / Pathology Clinical signs / pathology
Danish: Dosisjustering baseret på kliniske tegn/patologi Kliniske tegn/patologi
English: Therefore, the dosage given should be as described by your veterinarian, even if this is different from the dosing table.
Danish: Derfor bør den dosis, som gives, være som angivet af dyrlægen, selvom denne kan afvige fra doseringstabellen.
English: Palladia-treated dogs had a significantly greater objective response rate (37.2 %) compared to dogs treated with placebo (7.9 %).
Danish: Hunde, som blev behandlet med Palladia havde en signifikant højere objektiv responsrate (37,2%) sammenlignet med placebo-behandlede hunde (7,9%).
English: 10 mg (blue)
Danish: 10 mg (blå)
English: In an in-vitro study, metabolism of toceranib was primarily to the N-oxide derivative in dogs and cats.
Danish: I et in vitro-studie blev toceranib primært metaboliseret til N-oxidderivatet hos hunde og katte.
English: Maintain dose level
Danish: Oprethold dosis
English: As angiogenesis is a critical component of embryonic and foetal development, inhibition of angiogenesis following administration of Palladia should be expected to result in adverse effects on the pregnancy in the bitch.
Danish: Da angiogenese er en kritisk del af embryonal og føtal udvikling, må det forventes, at hæmning af angiogenesen efter administration af Palladia medfører bivirkninger på graviditeten hos tæven.
English: In case of tumour progression, treatment is unlikely to be successful and should be reviewed.
Danish: Ved tumorprogression er det usandsynligt, at behandlingen vil være succesfuld og bør revurderes.
English: 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: Evaluations should include assessment of clinical signs reported by the pet owner.
Danish: Evaluering bør omfatte vurdering af de kliniske tegn, der er rapporteret af hundeejeren.
English: Maintain dose level; discontinue hepatotoxic drugs, if used
Danish: Oprethold dosis; seponer hepatotoksiske lægemidler, hvis anvendt
English: Following oral administration of toceranib phosphate, approximately 92% of the administered drug is excreted in faeces with another 7% excreted in urine.
Danish: Efter peroral administration af toceranibphosphat blev cirka 92% af det administrerede lægemiddel udskilt med fæces og 7% udskilt med urinen.
English: The absolute bioavailability of toceranib when dosed orally at 3.25 mg/kg was determined to be 86%.
Danish: Toceranibs absolutte biotilgængelighed ved peroral dosering ved 3,25 mg/kg blev bestemt til 86%.
English: • Two dogs developed epistaxis that was not associated with thrombocytopenia.
Danish: • To hunde udviklede epistaksis, der ikke var associeret med trombocytopeni.
English: Do not use in dogs with gastrointestinal bleeding.
Danish: Bør ikke anvendes til hunde med gastrointestinal blødning.
English: • There were two deaths that were possibly treatment related.
Danish: • Der forekom to dødsfald, der muligvis var relateret til behandlingen.
English: Maintain dose level and institute supportive care
Danish: Oprethold dosisniveau og iværksæt understøttende behandling
English: Toceranib exerts an antiproliferative effect on endothelial cells in-vitro.
Danish: Toceranib udviser en antiproliferativ virkning på endotele celler in vitro.
English: It is important to show the doctor a copy of this package leaflet.
Danish: Det er vigtigt at vise lægen denne indlægsseddel.
English: The safety of Palladia was evaluated in mast cell tumour-bearing dogs with the following:
Danish: Palladias sikkerhed er vurderet hos mastcelletumor-bærende hunde med følgende:
English: No information relating to potential crossresistance with other cytostatics products is available.
Danish: Der foreligger ingen information om potentiel krydsresistens med andre cytostatika.
English: Dogs carrying wild-type c-kit and dogs carrying mutated c-kit responded significantly better to treatment as compared to placebo.
Danish: Hunde, der var bærere af vild-type c-kit, og hunde, der var bærere af muteret c-kit, responderede signifikant bedre på behandling end på placebo.
English: Anaemia and neutropaenia and eosinopaenia were doserelated.
Danish: Anæmi, neutropeni og eosinopeni var dosisrelateret.
English: >4 watery stools/day or ≥2 days
Danish: >4 vandige afføringer/dag eller ≥2
English: Linear pharmacokinetics were seen irrespective of the route of administration at doses up to 5 mg/kg given twice daily.
Danish: Der sås en lineær farmakokinetik uanset administrationsvej ved doser op til 5 mg/kg administreret to gange dagligt.
English: If systemic mastocytosis is present, standard pre-emptive care (e.g., H-1 and H-2 blockers) should be implemented prior to initiation of Palladia to avoid or minimize clinically significant mast cell degranulation and subsequent potentially severe systemic side effects.
Danish: Ved systemisk mastocytose skal forebyggende standardbehandling (f.eks. H-1- og H-2-blokkere) implementeres før initiering af behandling med Palladia for at undgå eller minimere klinisk signifikant mastcelledegranulering og efterfølgende potentielt alvorlige systemiske bivirkninger.
English: *A 0.5 mg/kg dose decrease is a decrease from 3.25 mg/kg to 2.75 mg/kg or from 2.75 mg/kg to 2.25 mg/kg.
Danish: * En dosisreduktion på 0,5 mg/kg er en nedsættelse af dosis fra 3,25 mg/kg til 2,75 mg/kg eller fra 2,75 mg/kg til 2,25 mg/kg.
English: Use non-steroidal anti-inflammatory drugs with caution in conjunction with Palladia due to an increased risk of gastrointestinal ulceration or perforation.
Danish: Non-steroide anti-inflammatoriske lægemidler skal anvendes med forsigtighed sammen med Palladia, da der er en øget risiko for gastrointestinal ulceration eller perforation.
English: Dogs in the 6 mg/kg every other day group exhibited the most adverse effects which included decreased food consumption and weight loss.
Danish: Hunde i gruppen, der fik 6 mg/kg hver anden dag, udviste de alvorligste bivirkninger, som inkluderede nedsat fødeindtagelse og vægttab.
English: Palladia may impair male and female fertility and embryo/foetal development.
Danish: Palladia kan nedsætte mandlig og kvindelig fertilitet og den embryonale/føtale udvikling.
English: Gastrointestinal discomfort such as vomiting or diarrhoea may occur if this drug is accidentally ingested.
Danish: Gastrointestinale gener som f.eks. opkastning eller diarré kan forekomme, hvis dette veterinære lægemiddel indtages ved et uheld.
English: 50 mg (red)
Danish: 50 mg (rød)
English: PACKAGE SIZE 20 tablets.
Danish: PAKNINGSSTØRRELSE 20 tabletter
English: The dose given should be based on veterinary assessments conducted weekly for the first six weeks and, thereafter, every six weeks.
Danish: Den givne dosis bør baseres på dyrlægens vurderinger, som udføres ugentligt de første 6 uger og derefter hver 6. uge.