FrancophonIA/ELRC3.0 huggingface dataset:
English: What measures are being taken to ensure the safe and effective use of Orfadin?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Orfadin?
English: Thrombocytopenia (low blood platelet counts), leucopenia (low white blood cell counts), granulocytopenia (low levels of granulocytes, a type of white blood cell), conjunctivitis (inflammation of the membrane that lines the eyelid), corneal opacity (clouding of the cornea, the transparent layer in front of the pupil), keratitis (inflammation of the cornea), photophobia (increased sensitivity of the eyes to light) and eye pain are also common (seen in between 1 and 10 patients in 100).
Danish: Denne bivirkning ses hos mere end 1 patient ud af 10. Trombocytopeni (for lavt antal blodplader), leukopeni (for lavt antal hvide blodlegemer), granolytopeni (for lavt indhold af granulocytter, en type hvide blodlegemer), konjunktivitis (betændelse i den membran, der dækker øjets forreste halvdel), corneauklarhed (tilsløring af hornhinden, det gennemsigtige lag foran pupillen), keratitis (betændelse i hornhinden), lysfølsomhed og øjensmerter er også almindelige (optræder hos mellem 1 og 10 patienter ud af 100).
English: For more information about treatment with Orfadin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Orfadin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP noted that Orfadin seems to be an effective treatment for HT-1, particularly if it is started early, before the patient's liver is too damaged.
Danish: CHMP noterede sig, at Orfadin synes at være effektivt til behandling af HT-1, især hvis behandlingen indledes, inden patientens lever er alt for beskadiget.
English: Treatment with Orfadin should be started and monitored by doctors who have experience in the treatment of patients with HT-1.
Danish: Behandlingen med Orfadin bør indledes og overvåges af en læge, der har erfaring i behandling af patienter med HT-1.
English: Treatment should be started as early as possible and the dose of Orfadin adjusted according to the patient's response and body weight.
Danish: Behandlingen bør indledes hurtigst muligt, og Orfadin-dosis tilpasses patientens behandlingsrespons og legemsvægt.
English: Orfadin was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of the approval.
Danish: Orfadin blev oprindeligt godkendt under "særlige omstændigheder", da der på godkendelsestidspunktet ikke forelå fyldestgørende oplysninger, fordi sygdommen er sjælden.
English: The main benefit of Orfadin is to greatly extend life expectancy.
Danish: Den største fordel ved Orfadin er, at den i væsentlig grad forlænger levetiden.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Orfadin.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Orfadin skal anvendes.
English: Orfadin is used to treat hereditary tyrosinaemia type 1 (HT-1).
Danish: Orfadin anvendes til behandling af arvelig tyrosinæmi type 1 (HT-1).
English: The full EPAR for Orfadin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Orfadin findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Orfadin is a medicine that contains the active substance nitisinone.
Danish: Orfadin er et lægemiddel, der indeholder det aktive stof nitisinon.
English: Orfadin is intended for long-term use.
Danish: Orfadin er beregnet til langtidsbehandling.
English: Orfadin also provides a better outcome for patients than that reported in the literature in patients eating a modified diet alone.
Danish: Orfadin giver desuden bedre resultater hos patienterne end dem, der fremgår af litteraturen for patienter, der udelukkende får en ændret diæt.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Orfadin, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Orfadin, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Patients with HT-1 lack one of these enzymes, so tyrosine is not properly eliminated but is transformed into harmful substances.
Danish: Patienter med HT-1 mangler et af disse enzymer, så tyrosinet i deres krop nedbrydes ikke, som den skulle, men omdannes i stedet til skadelige stoffer.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Orfadin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Orfadin findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: For the full list of all side effects and restrictions with Orfadin, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Orfadin fremgår af indlægssedlen.
English: The active substance in Orfadin, nitisinone, blocks an enzyme that converts tyrosine into harmful substances.
Danish: Det aktive stof i Orfadin, nitisinon, blokerer et enzym, der omdanner tyrosin til skadelige stoffer.
English: What is the risk associated with Orfadin?
Danish: Hvilken risiko er der forbundet med Orfadin?
English: Therefore, the CHMP decided that Orfadin's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP var af den opfattelse, at fordelene ved Orfadin opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Orfadin.
English: The study looked at the effect of Orfadin on survival, and compared this with reports published in medical journals describing survival in patients with HT-1 who were only receiving a modified diet.
Danish: Undersøgelsen så på Orfadins virkning på overlevelsestiden og sammenlignede denne med rapporter i lægetidsskrifter om overlevelsestid for HT-1-patienter, som kun fik en ændret diæt.
English: Orfadin is used together with a diet that restricts the intake of the amino acids tyrosine and phenylalanine.
Danish: Orfadin anvendes i kombination med en diæt med begrænset indtagelse af aminosyrerne tyrosin og phenylalanin.
English: However, as tyrosine remains in the body during Orfadin treatment, patients need to eat a special diet low in tyrosine.
Danish: Tyrosin forbliver dog i kroppen under behandlingen med Orfadin, og patienterne skal derfor følge en særlig diæt med et lavt indhold af tyrosin.
English: Why has Orfadin been approved?
Danish: Hvorfor blev Orfadin godkendt?
English: The oral suspension is for children who have difficulty swallowing capsules.
Danish: Den orale opløsning er beregnet til børn med synkebesvær.
English: What is Orfadin?
Danish: Hvad er Orfadin?
English: What benefit has Orfadin shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Orfadin?
English: Treatment with Orfadin leads to high levels of tyrosine in the blood (due to the medicine's mode of action); this side effect is seen in more than 1 patient in 10.
Danish: Behandlingen med Orfadin medfører et for højt tyrosinniveau i blodet (pga. lægemidlets virkemåde).
English: How has Orfadin been studied?
Danish: Hvordan blev Orfadin undersøgt?
English: What is Orfadin used for?
Danish: Hvad anvendes Orfadin til?
English: This is a rare disease in which the body is unable to completely break down the amino acid tyrosine, and harmful substances are formed, causing serious liver problems and liver cancer.
Danish: Derved dannes der skadelige stoffer, som hober sig op i kroppen, hvilket medfører svære leverproblemer og leverkræft.
English: How is Orfadin used?
Danish: Hvordan anvendes Orfadin?
English: How does Orfadin work?
Danish: Hvordan virker Orfadin?
English: Via del Commercio 25/27 63100 Marino Del Tronto (AP) ITALY
Danish: Via del Commercio 25/27 63100 Marino Del Tronto (AP) ITALIEN
English: These tablets can be administered with or without food.
Danish: Tabletterne kan administreres med eller uden foder.
English: Anaemia and lymphoma have been reported very rarely in spontaneous reports.
Danish: Anæmi og lymfom er meget sjældent rapporteret i spontane rapporter.
English: Neither of these clinical pathology changes appeared clinically significant.
Danish: Ingen af disse klinisk patologiske ændringer var klinisk signifikante.
English: Date of first authorisation: 12/09/2013.
Danish: Dato for første markedsføringstilladelse: 12/09/2013.
English: Dogs should be carefully observed following administration to ensure that each tablet is swallowed.
Danish: Hunde bør observeres omhyggeligt efter administration for at sikre, at hver enkelt tablet er slugt.
English: Date of last renewal: 26/07/2018.
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 26/07/2018.
English: One major oxidative metabolite was identified in plasma and urine.
Danish: Én oxidativ hovedmetabolit blev identificeret i plasma og urin.
English: Do not use in dogs less than 12 months of age or less than 3 kg bodyweight.
Danish: Bør ikke anvendes til hunde, der er yngre end 12 måneder eller som vejer mindre end 3 kg.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the blister or bottle after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på blisterpakningen eller flasken efter EXP.
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Macrogol 400 (E1521)
Danish: Lactosemonohydrat Hypromellose (E464) Titandioxid (E171) Macrogol 400 (E1521)
English: There is no specific antidote and in case of signs of overdose the dog should be treated symptomatically.
Danish: Der findes intet specifikt antidot og ved tegn på overdosis bør hunden behandles symptomatisk.
English: The prandial state of the dog does not significantly affect the rate or extent of its absorption.
Danish: Hundens prandiale tilstand har ingen signifikant virkning på absorptionshastighed eller -grad.
English: Therefore, the risk of metabolic drug-drug interactions due to oclacitinib inhibition is very low.
Danish: Derfor er risikoen for metabolisk lægemiddel-lægemiddelinteraktioner på grund af oclacitinibhæmning meget lav.
English: Oclacitinib modulates the immune system and may increase susceptibility to infection and exacerbate neoplastic conditions.
Danish: Oclacitinib modulerer immunsystemet og kan øge følsomheden for infektion og forværre neoplastiske tilstande.
English: The absolute bioavailability of oclacitinib maleate was 89%.
Danish: Oclacitinibmaleats absolutte biotilgængelighed var 89 %.
English: Adverse reactions observed in pruritus study up to day 7
Danish: Bivirkninger observeret i studier af pruritus frem til dag 7
English: No accumulation was observed in the blood of dogs treated for 6 months with oclacitinib.
Danish: Der blev ikke observeret akkumulering i blodet hos hunde, der blev behandlet i 6 måneder med oclacitinib.
English: The dosing table below shows the number of tablets required.
Danish: Doseringstabellen nedenfor viser det antal tabletter, der er behov for.
English: The tablets can be divided into equal halves.
Danish: Tabletterne kan deles i lige store dele.
English: Papilloma was considered treatment related, but not dose related.
Danish: Papilloma blev anset for at være behandlingsrelateret men ikke dosisrelateret.
English: Dosage and treatment schedule:
Danish: Dosering og behandlingsplan:
English: polydipsia, lymphadenopathy, nausea, increased appetite and aggression have been observed commonly.
Danish: lipom, polydipsi, lymfadenopati, kvalme, øget appetit og aggression er blevet observeret som almindeligt.
English: Following oral administration in dogs, oclacitinib maleate is rapidly and well absorbed, with a time to peak plasma concentration (tmax) of less than 1 hour.
Danish: Efter oral administration til hunde absorberes oclacitinibmaleat hurtigt og godt med en tid til maksimal plasmakoncentration (tmax) på mindre end 1 time.
English: Following intravenous and oral administration, the terminal t1/2s were similar at 3.5 and 4.1 hours respectively.
Danish: Efter intravenøs og oral administration var den terminale halveringstid t½ ens ved hhv. 3,5 og 4,1 time.
English: Disposal: read the package leaflet.
Danish: Bortskaffelse: læs indlægssedlen.
English: Dogs receiving Apoquel tablets should therefore be monitored for the development of infections and neoplasia.
Danish: Hunde der får Apoquel tabletter, bør derfor monitoreres for udvikling af infektioner og neoplasmer.
English: The clinical relevance of these observed effects for animals vaccinated while being administered oclacitinib (in accordance with the recommended dosing regimen) is unclear.
Danish: Den kliniske relevans af de observerede virkninger hos vaccinerede dyr, der samtidig fik administration af oclacitinib (i overensstemmelse med det anbefalede dosisregimen), er uklar.
English: ATC vet code: QD11AH90.
Danish: kortikosteroider ATCvet-kode: QD11AH90
English: However, the findings of this study indicated a reduction in serological response to vaccination with CPI and RV in puppies being treated with oclacitinib compared to untreated controls.
Danish: Resultaterne af dette studie indikerer dog en reduktion i serologisk respons over for vaccination med CPI og RV hos hvalpe, der var i behandling med oclacitinib sammenlignet med den ikke-behandlede kontrolgruppe.
English: 1BANNEX II
Danish: 1BBILAG II
English: 20 tablets 50 tablets 100 tablets
Danish: 20 tabletter 50 tabletter 100 tabletter
English: Oclacitinib is a Janus kinase (JAK) inhibitor.
Danish: Oclacitinib er en Janus kinase (JAK)-hæmmer.
English: It can inhibit the function of a variety of cytokines dependent on JAK enzyme activity.
Danish: Det kan hæmme virkningen af forskellige cytokiner afhængigt af JAK-enzym-aktivitet.
English: All tablets strengths are packaged in either aluminium/PVC/Aclar blisters (each strip containing 10 film-coated tablets) packed into an outer cardboard box, or white HDPE plastic bottle with child resistant closure.
Danish: Alle tabletstyrker er pakket enten i aluminium/PVC/Aclar blisterkort (hver strip indeholder 10 filmovertrukne tabletter) i en ydre æske af karton eller hvid HDPE-flaske med en børnesikret lukning.
English: However, oclacitinib may also exert effects on other cytokines (for example, those involved in host defence or haematopoiesis) with the potential for unwanted effects.
Danish: Oclacitinib kan imidlertid også påvirke virkningen af andre cytokiner (f.eks. cytokiner der er involveret i værtsforsvar eller hæmatopoiese) med risiko for bivirkninger.
English: Any remaining half tablets should be discarded after 3 days.
Danish: Resterende halve tabletter skal bortskaffes efter 3 dage.
English: White to off-white, oblong shaped film-coated tablets with a score-line on both sides and marked with the letters "AQ" and "S", "M" or "L" on both sides.
Danish: Hvide til næsten hvide, aflange, filmovertrukne tabletter med en delekærv på begge sider og præget med bogstaverne ”AQ” og ”S”, ”M” eller ”L” på begge sider.
English: For oclacitinib, the target cytokines are those that are proinflammatory or have a role in allergic responses/pruritis.
Danish: Målcytokiner for oclacitinib er de cytokiner, der er proinflammatoriske og som spiller en rolle ved allergisk respons/pruritus.
English: Apoquel tablets are supplied in either blister packs or bottles with 20, 50 or 100 tablets per pack.
Danish: Apoquel tabletter fås i blisterpakninger eller HDPE flaske med 20, 50 eller 100 tabletter pr. pakning.
English: Cellulose, microcrystalline Lactose monohydrate Magnesium stearate Sodium starch glycolate
Danish: Cellulose, mikrocrystallinsk Lactosemonohydrat Magnesiumstearat Natriumstivelsesglycolat
English: The impact of oclacitinib administration on vaccination with modified live vaccines, canine parvovirus (CPV), canine distemper virus (CDV) and canine parainfluenza (CPI) and inactivated rabies vaccine (RV), on 16 week old vaccine naïve puppies has been studied.
Danish: Påvirkningen af oclacitinibadministrationen på vaccination med modificerede, levende vacciner, hundeparvovirus (CPV), hundedistempervirus (CDV) og hundeparainfluenza (CPI) samt inaktiveret rabiesvaccine (RV) hos 16-uger gamle vaccine-naïve hvalpe er blevet undersøgt.
English: Pack sizes of 20, 50 or 100 tablets.
Danish: Pakninger med 20, 50 eller 100 tabletter.
English: Oclacitinib exhibits low protein binding with 66.3% to 69.7% bound in fortified canine plasma at nominal concentrations ranging from 10 to 1,000 ng/ml.
Danish: Oclacitinib udviser lav proteinbinding med 66,3 % til 69,7 % bundet til beriget hundeplasma ved nominelle koncentrationer i området 10 til 1.000 ng/ml.
English: Inhibition of canine cytochrome P450s is minimal with IC50s 50-fold greater than the observed mean Cmax (333 ng/ml or 0.997 µM) following 0.6 mg/kg bw oral administration in the target animal safety study.
Danish: Hæmning af hundecytochrom P450 er minimal med IC50 50 gange større end det observerede gennemsnitlige Cmax (333 ng/ml eller 0,997 mikroM) efter 0,6 mg/kg kv oral administration i sikkerhedsstudiet af måldyr.
English: Please see dosing table below for the number of tablets required to achieve the recommended dose.
Danish: Doseringstabellen nedenfor viser det antal tabletter, der er behov for, for at opnå den anbefalede dosis.
English: Total body oclacitinib clearance from plasma was low - 316 ml/h/kg bodyweight (5.3 ml/min/kg bodyweight), and the apparent volume of distribution at steady-state was 942 ml/kg bodyweight.
Danish: Oclacitinibs totale kropsclearance fra plasma var lav - 316 ml/t/kg kropsvægt (5,3 ml/min/kg kropsvægt) og det tilsyneladende distributionsvolumen ved steady-state var 942 ml/kg kropsvægt.
English: The requirement for long-term maintenance therapy should be based on an individual benefit-risk assessment.
Danish: Nødvendigheden af langtidsbehandling bør baseres på individuel vurdering af fordele og risici.
English: Regarding susceptibility to infection and neoplastic conditions, see section 4.5.
Danish: For følsomhed over for infektioner og neoplastiske tilstande, se pkt.
English: The letters "S", "M" and "L" refer to the different strengths of tablets: "S" is on the 3.6 mg tablets, "M" on the 5.4 mg tablets, and "L" on the 16 mg tablets.
Danish: Bogstaverne ”S”, ”M” og ”L” henviser til tabletternes forskellige styrker: ”S” er på tabletterne med 3,6 mg, ”M” er på tabletterne med 5,4 mg og ”L” er på tabletterne med 16 mg.
English: Treatment-related clinical pathology changes were restricted to an increase in mean serum cholesterol and a decrease in mean leukocyte count, however, all mean values remained within the laboratory reference range.
Danish: Behandlingsrelaterede klinisk-patologiske ændringer var begrænset til stigning i gennemsnitlig serumcholesterol og et fald i gennemsnitlig leukocyttal, alle middelværdier forblev dog inden for det laboratoriske referenceområde.
English: Do not use in dogs with evidence of immune suppression such as hyperadrenocorticisim or with evidence of progressive malignant neoplasia as the active substance has not been evaluated in these cases.
Danish: Bør ikke anvendes til hunde med tegn på immunsuppression, så som hyperadrenocorticisme eller med tegn på progressiv, malign neoplasme, da det aktive stof ikke er undersøgt i disse tilfælde.
English: Strength and number of tablets to be administered: Apoquel 3.6 mg tablets
Danish: Styrke og antal tabletter, der skal administreres: Apoquel 3,6 mg tabletter
English: Treatment of pruritus associated with allergic dermatitis in dogs.
Danish: Behandling af pruritus i forbindelse med allergisk dermatitis hos hunde.
English: Treatment of clinical manifestations of atopic dermatitis in dogs.
Danish: Behandling af kliniske manifestationer på atopisk dermatitis hos hunde.
English: Shelf life of the veterinary medicinal product as packaged for sale in blisters: 2 years.
Danish: Opbevaringstid for veterinærlægemidlet i blisterpakning: 2 år.
English: The requirement for longterm maintenance therapy should be based on an individual benefit-risk assessment by the responsible veterinarian.
Danish: Nødvendigheden af langtidsbehandling bør baseres på den ansvarlige dyrlæges individuelle vurdering af fordele og risici.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation, or in breeding male dogs, therefore its use is not recommended during pregnancy, lactation or in dogs intended for breeding.
Danish: Lægemidlets sikkerhed under drægtighed og laktation, eller hos hanhunde til avl, er ikke fastlagt, derfor frarådes anvendelse under drægtighed, laktation eller hos hunde, der er beregnet til avl.
English: No drug interactions were observed in field studies where oclacitinib was administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials and antiinflammatories.
Danish: Ingen lægemiddelinteraktioner blev observeret i feltstudier, hvor oclacitinib blev administreret samtidig med veterinærlægemidler så som endo- og ektoparasiticider, antimikrobielle lægemidler og antiinflammatoriske lægemidler.
English: The common adverse reactions seen up to day 16 of the field trials are listed in the following table: Adverse reactions observed in atopic dermatitis study up to day 16
Danish: De almindelige bivirkninger, der er observeret frem til dag 16 i feltstudier, er anført i følgende tabel: Bivirkninger observeret i studier af atopisk dermatitis frem til dag 16
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE LABEL for Bottle
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET TIL FLASKE
English: After day 16, the following adverse reactions have been observed: - pyoderma and non-specified dermal lumps have been observed very commonly; - otitis, vomiting, diarrhoea, histiocytoma, cystitis, yeast skin infections, pododermatitis, lipoma,
Danish: Efter dag 16 er følgende bivirkninger blevet observeret: - pyoderma og ikke-specificerede dermale knuder er blevet observeret som meget almindeligt - otitis, opkastning, diarré, histiocytom, cystitis, hudinfektioner med gærsvamp, pododermatitis,
English: Oclacitinib is metabolised in the dog to multiple metabolites.
Danish: Hos hunde metaboliseres oclacitinib til adskillige metabolitter.
English: An adequate immune response (serology) to CDV and CPV vaccination was achieved when puppies were administered oclacitinib at 1.8 mg/kg bodyweight (bw) twice daily for 84 days.
Danish: Der blev opnået et tilstrækkeligt immunrespons (serologi) over for CDV- og CPV-vaccination, når hvalpe fik oclacitinib 1,8 mg/kg kropsvægt (kv) to gange dagligt i 84 dage.
English: Overall the major clearance route is metabolism, with minor contributions from renal and biliary elimination.
Danish: Metabolisme er overordnet den primære udskillelsesvej med mindre grad af elimination via nyrer og galde.
English: New cutaneous or subcutaneous lumps Lethargy
Danish: Nye kutane eller subkutane knuder Letargi
English: The development of papillomas was noted in a number of dogs in a laboratory study.
Danish: I en laboratorieundersøgelse sås udvikling af papillomer hos nogle hunde.