FrancophonIA/ELRC3.0 huggingface dataset:
English: Use of Riarify in patients with severe renal impairment or end-stage renal disease requiring dialysis, especially if associated with significant body weight reduction, should be considered only if the expected benefit outweighs the potential risk (see section 4.4 and section 5.2).
Danish: Anvendelsen af Riarify til patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet der kræver dialyse, især hvis det er forbundet med en signifikant vægttab, bør kun overvejes, hvis den forventede fordel opvejer den mulige risiko (se pkt.
English: Store at 25°C for a maximum of 2 months.
Danish: Opbevares ved 25 °C i maksimalt 2 måneder.
English: Hyperaemia1, flushing1, hypertension
Danish: Hyperæmi1, rødme1, hypertension
English: - when using the container providing 180 puffs
Danish: - når du bruger beholderen, der leverer 180 pust
English: Use of the inhaler
Danish: Brug af inhalatoren
English: Hypersomnia
Danish: Hypersomni
English: - when using the container providing 60 puffs
Danish: - når du bruger beholderen, der leverer 60 pust
English: Concomitant use of other beta-adrenergic medicinal products can have potentially additive effects; therefore, caution is required when other beta-adrenergic medicinal products are prescribed concomitantly with formoterol.
Danish: Derfor rådes der til forsigtighed, når andre beta-adrenerge lægemidler ordineres samtidigt med formoterol.
English: TRISTAR was a 26-week active-controlled open label study comparing Riarify with an extemporary combination made of a fixed combination of fluticasone/vilanterol 92/22 micrograms inhalation powder, one inhalation once daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (1,157 randomised patients).
Danish: TRISTAR var et 26-ugers, åbent, aktivt kontrolleret studie, der sammenlignede Riarify med en ekstemporær kombination bestående af en fastdosiskombination af fluticason/vilanterol 92/22 mikrogram inhalationspulver, en inhalation én gang dagligt plus tiotropium 18 mikrogram inhalationspulver, hård kapsel, en inhalation én gang dagligt (1.157 randomiserede patienter).
English: • runny or stuffy nose and sneezing
Danish: • løbende eller tilstoppet næse og nysen
English: Cough, productive cough1, throat irritation, epistaxis1
Danish: Hoste, produktiv hoste1, halsirritation, epistaxis1
English: Compared with tiotropium, Riarify improved pre-dose FEV1 by 51 mL after 26 weeks of treatment and by 61 mL after 52 weeks of treatment.
Danish: Sammenlignet med tiotropium forbedrede Riarify FEV1 før dosering med 51 ml efter 26 ugers behandling og med 61 ml efter 52 ugers behandling.
English: 1 pressurised container of 180 actuations.
Danish: 1 trykbeholder med 180 pust.
English: Pre-dose FEV1
Danish: FEV1 før dosering
English: Growth retardation1
Danish: Vækstretardation1
English: 120 and 180 actuation pressurised container:
Danish: Trykbeholder med 120 og 180 pust:
English: 1 pressurised container of 120 actuations.
Danish: 1 trykbeholder med 120 pust.
English: 1 pressurised container of 60 actuations.
Danish: 1 trykbeholder med 60 pust.
English: The other ingredients are: ethanol anhydrous, hydrochloric acid, propellant: norflurane.
Danish: Øvrige indholdsstoffer: vandfrit ethanol, saltsyre, drivmiddel: norfluran.
English: After use, replace the protective cap.
Danish: Sæt beskyttelseslåget på igen efter brug.
English: Effect of renal impairment
Danish: Virkning af nedsat nyrefunktion
English: • dry throat
Danish: • tør i halsen
English: Pressurised inhalation, solution.
Danish: Inhalationsspray, opløsning.
English: - when using the container providing 120 puffs
Danish: - når du bruger beholderen, der leverer 120 pust
English: After inhaling, patients should rinse their mouth or gargle with water without swallowing it or brush their teeth (see sections 4.2 and 4.4).
Danish: Efter inhalation skal patienterne skylle munden eller gurgle med vand uden at synke det eller børste tænder (se pkt.
English: You should not use Riarify during breast-feeding.
Danish: Du må ikke anvende Riarify under amning.
English: Glycopyrronium bromide is a high affinity muscarinic receptor antagonist with a greater than 4-fold selectivity for the human M3 receptors over the human M2 receptor as it has been demonstrated.
Danish: Glycopyrronium virker ved at blokere den bronkokonstiktive virkning af acetylcholin på de glatte muskelceller i luftvejene, og derved dilatere dem. Glycopyrroniumbromid er en muskarinreceptor med en høj affinitet, og der er blevet påvist en selektivitet over for humane M3-receptorer, der var 4-gange større end for humane M2-receptorer.
English: • irregular heart beat
Danish: • uregelmæssigt hjerteslag
English: Before priming the 60, 120 or 180 actuation pressurised containers, the counter/indicator should read 61, 121 or 180, respectively.
Danish: Før trykbeholderne med 60, 120 eller 180 pust primes, skal der stå henholdsvis.
English: Take care not to drop the inhaler as this may cause the counter to count down.
Danish: Sørg for ikke at tabe inhalatoren, da det kan få dosistælleren til at tælle ned.
English: Priming the inhaler
Danish: Priming af inhalatoren
English: IMPORTANT: steps 2 to 5 should not be performed too quickly: Patients should remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects.
Danish: Patienterne skal fjerne beskyttelseslåget fra mundstykket og kontrollere, at mundstykket er rent og uden støv og snavs eller andre fremmedlegemer.
English: 60 actuation pressurised container:
Danish: Trykbeholder med 60 pust:
English: Compared with a fixed combination of indacaterol and glycopyrronium, Riarify reduced the rate of moderate/severe exacerbations over 52 weeks by 15% (rate: 0.50 versus 0.59 events per patient/year; p = 0.043).
Danish: Sammenlignet med en fastdosiskombination af indacaterol og glycopyrronium nedsatte Riarify hyppigheden af moderate/svære eksacerbationer i løbet af 52 uger med 15 % (hyppighed: 0,50 versus 0,59 hændelser pr. patient/år, p = 0,043).
English: Thrombocytopenia1
Danish: Trombocytopeni1
English: Additionally, due to the anticholinergic effect of glycopyrronium, the long-term co-administration of Riarify with other anticholinergic-containing medicinal products is not recommended (see section 4.5).
Danish: Desuden bør en langvarig administration af Riarify sammen med andre lægemidler, der indeholder antikolinergika, ikke anvendes, på grund af den antikolinerge virkning af glycopyrronium (se pkt.
English: • feeling breathless or short of breath
Danish: • åndenød eller stakåndethed
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Riarify significantly improved 2-hour post dose FEV1 by 117 mL after 26 weeks of treatment and by 103 mL after 52 weeks of treatment (p < 0.001).
Danish: Sammenlignet med en fast kombination af beclometasondipropionat og formoterol forbedrede Riarify FEV1 2-timer efter dosering med 117 ml efter 26 ugers behandling, og med 103 ml efter 52 ugers behandling (p < 0,001).
English: After priming, the counter/indicator should read 60, 120 or 180.
Danish: Efter priming skal der stå 60, 120 eller 180 på dosistælleren/indikatoren.
English: • fungal infections of the chest
Danish: • svampeinfektioner i skeden
English: Beclometasone is less dependent on CYP3A metabolism than some other corticosteroids, and in general interactions are unlikely; however, the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded, and therefore caution and appropriate monitoring is advised with the use of such medicinal products.
Danish: Beclometason er mindre afhængig af CYP3A-metabolisering end visse andre kortikosteroider, og generelt er interaktion ikke sandsynlig.
English: Package leaflet: Information for the user Riarify 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Danish: Indlægsseddel: Information til brugeren Riarify 87 mikrogram/5 mikrogram/9 mikrogram inhalationsspray, opløsning beclometasondipropionat/formoterolfumaratdihydrat/glycopyrronium (beclometasoni dipropionas/formoteroli fumaras dihydricus/glycopyrronium)
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Riarify reduced the rate of moderate/severe exacerbations over 52 weeks by 23% (rate: 0.41 versus 0.53 events per patient/year; p = 0.005).
Danish: Sammenlignet med en fastdosiskombination af beclometasondipropionat og formoterol nedsatte Riarify hyppigheden af moderate/svære eksacerbationer i løbet af 52 uger med 23 % (hyppighed: 0,41 versus 0,53 hændelser pr. patient/år, p = 0,005).
English: The daily dose of Riarify corresponds to a medium dose of inhaled corticosteroid; furthermore, these effects are much less likely to occur than with oral corticosteroids.
Danish: Den daglige dosis af Riarify svarer til en medium dosis af inhaleret kortikosteroid.
English: Riarify 87/5/9 micrograms pressurised inhalation beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium Inhalation use
Danish: Riarify 87/5/9 mikrogram inhalationsspray beclometasoni dipropionas/formoteroli fumaras dihydricus/glycopyrronium Til inhalation
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Riarify improved pre-dose FEV1 by 81 mL after 26 weeks of treatment and by 63 mL after 52 weeks of treatment.
Danish: Sammenlignet med en fast kombination af beclometasondipropionat og formoterol forbedrede Riarify FEV1 før dosering med 81 ml efter 26 ugers behandling og med 63 ml efter 52 ugers behandling.
English: Compared with tiotropium, Riarify reduced the rate of moderate/severe exacerbations over 52 weeks by 20% (rate: 0.46 versus 0.57 events per patient/year; p = 0.003).
Danish: Sammenlignet med tiotropium nedsatte Riarify hyppigheden af moderate/svære eksacerbationer i løbet af 52 uger med 20 % (hyppighed: 0,46 versus 0,57 hændelser pr. patient/år, p = 0,003).
English: Patients with severe renal impairment
Danish: Patienter med svært nedsat leverfunktion
English: Riarify 87/5/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Danish: Riarify 87/5/9 mikrogram inhalationsspray, opløsning beclometasoni dipropionas/formoteroli fumaras dihydricus/glycopyrronium
English: For the 180 actuation pressurised container, each time the patient presses the pressurised container a puff of the solution is released and the counter rotates by a small amount; the number of puffs remaining is displayed in intervals of 20.
Danish: For trykbeholderen med 180 pust vil der blive frigivet en dosis af opløsningen, hver gang patienten trykker på trykbeholderen, og dosistælleren roterer lidt.
English: Excipients: anhydrous ethanol, hydrochloric acid; propellant: norflurane.
Danish: Hjælpestoffer: vandfri ethanol, saltsyre, drivmiddel: norfluran.
English: Inhaled beclometasone dipropionate is rapidly absorbed through the lungs; prior to absorption there is extensive conversion to beclometasone 17-monopropionate via esterase enzymes that are found in most tissues.
Danish: Forud for absorptionen finder der en omfattende konvertering til beclometason-17-monopropionat sted via esteraseenzymerne, der findes i de fleste væv.
English: The mean elimination half-life of glycopyrronium in healthy volunteers was approximately 6 hours after i.v.
Danish: Den gennemsnitlige halveringstid for elimination af glycopyrronium hos raske frivillige var ca. 6 timer efter i.v.-injektion, mens det varierede fra 5 til 12 timer ved steady state efter inhalation hos KOL-patienter.
English: Angioedema1
Danish: Angioødem1
English: Patients should hold the inhaler vertically with its body upwards and place the mouthpiece between their teeth without biting.
Danish: Hold inhalatoren opret med mundstykket forneden, og placer mundstykket mellem tænderne uden at bide i det.
English: Deterioration of disease
Danish: Sygdomsforværring
English: Colourless to yellowish liquid solution.
Danish: Farveløs til gullig, flydende opløsning.
English: • inflammation of the kidneys.
Danish: • nyrebetændelse.
English: • tiredness
Danish: • rysten
English: Each delivered dose contains 87 micrograms of beclometasone dipropionate, 5 micrograms of formoterol fumarate dihydrate and 9 micrograms of glycopyrronium.
Danish: Hver leverede dosis indeholder 87 mikrogram beclometasondipropionat, 5 mikrogram formoterolfumaratdihydrat og 9 mikrogram glycopyrronium.
English: How to use Riarify
Danish: Sådan skal du bruge Riarify
English: Patients with severe hepatic impairment
Danish: Patienter med svært nedsat nyrefunktion:
English: Bone density decreased1
Danish: Nedsat knoglemineralsk densitet1
English: • irritation of the throat
Danish: • ondt i halsen
English: Each metered dose (the dose leaving the valve) contains 100 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate and 10 micrograms of glycopyrronium.
Danish: Hver afmålte dosis (dosis, der forlader ventilen) indeholder 100 mikrogram beclometasondipropionat, 6 mikrogram formoterolfumaratdihydrat og 10 mikrogram glycopyrronium.
English: Compared with tiotropium, Riarify also reduced the rate of severe exacerbations (i.e. excluding moderate exacerbations) by 32% (rate: 0.067 versus 0.098 events per patient/year; p = 0.017).
Danish: moderate eksacerbationer) med 32 % (hyppighed: 0,067 versus 0,098 hændelser pr. patient/år, p = 0,017).
English: Each delivered dose (the dose leaving the mouthpiece) contains 87 micrograms of beclometasone dipropionate, 5 micrograms of formoterol fumarate dihydrate and 9 micrograms of glycopyrronium (as 11 micrograms glycopyrronium bromide).
Danish: Hver leveret dosis (dosis, der forlader mundstykket) indeholder 87 mikrogram beclometasondipropionat (beclometasoni dipropionas), 5 mikrogram formoterolfumaratdihydrat (formoteroli fumaras dihydricus) og 9 mikrogram glycopyrronium (glycopyrronium) (som 11 mikrogram glycopyrroniumbromid).
English: • inflammation of the ear
Danish: • ørebetændelse
English: Medicines should not be disposed of via waste water or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Study TRINITY compared Riarify with tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily; in addition, effects were compared with an extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (2,691 randomised patients).
Danish: Desuden blev virkningerne sammenlignet med en ekstemporær trippelkombination, der bestod af en fast kombination af to inhalationer af beclometasondipropionat og formoterol 100/6 mikrogram to gange dagligt plus tiotropium 18 mikrogram inhalationspulver, hård kapsel, en inhalation én gang dagligt (2.691 randomiserede patienter).
English: After dispensing, the medicinal product may be stored for a maximum of 4 months at a temperature up to 25°C.
Danish: Efter udlevering kan inhalatoren opbevares ved temperaturer op til 25 °C i maksimalt 4 måneder.
English: • if you are due to have an anaesthetic.
Danish: • hvis du skal bedøves.
English: • skin rash, hives, skin itching
Danish: • hududslæt, nældefeber, hudkløe
English: Ethanol anhydrous Hydrochloric acid Norflurane (propellant)
Danish: Ethanol, vandfrit Saltsyre
English: Dysuria, urinary retention, nephritis1
Danish: Nyrer og urinveje Dysuri, urinretention, nefritis1
English: Each metered dose (the dose leaving the valve) contains 100 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate and 10 micrograms of glycopyrronium (as 12.5 micrograms of glycopyrronium bromide).
Danish: Hver afmålte dosis (der forlader ventilen) indeholder 100 mikrogram beclometasondipropionat, 6 mikrogram formoterolfumaratdihydrat og 10 mikrogram glycopyrronium (som 12,5 mg glycopyrroniumbromid).
English: Each metered dose (the dose leaving the valve) contains 100 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate and 10 micrograms of glycopyrronium (as 12.5 micrograms glycopyrronium bromide).
Danish: Hver afmålte dosis (dosis, der forlader ventilen) indeholder 100 mikrogram beclometasondipropionat (beclometasoni dipropionas), 6 mikrogram formoterolfumaratdihydrat (formoteroli fumaras dihydricus) og 10 mikrogram glycopyrronium (glycopyrronium) (som 12,5 mikrogram glycopyrroniumbromid).
English: Restlessness1
Danish: Otosalpingitis1
English: Fatigue1
Danish: Træthed1
English: • inflammation and redness of the pharynx
Danish: • betændelse og rødme i svælget
English: • numbness
Danish: • træthed
English: This difference in favour of Galliprant was statistically significant (p-value= 0.0008).
Danish: Denne forskel til fordel for Galliprant var statistisk signifikant (p-værdi = 0,0008).
English: A clinical response to treatment is usually seen within 7 days.
Danish: Et klinisk respons på behandling ses sædvanligvis inden for 7 dage.
English: 26 Rue de la Chapelle 68330 Huningue France
Danish: 26 Rue de la Chapelle 68330 Huningue Frankrig
English: No gender related differences in absorption are observed.
Danish: Der observeres ingen kønsrelaterede forskelle i absorption.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/01/2018
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 09/01/2018
English: The elimination half-life of grapiprant is approximately 4.6 to 5.67 hours.
Danish: Halveringstiden for elimination af grapiprant er ca. 4,6 til 5,67 timer.
English: The following number of tablets should be given once daily:
Danish: Følgende antal af tabletter skal gives en gang dagligt:
English: Duration of treatment will depend on the response observed to treatment.
Danish: Varigheden af behandlingen vil afhænge af responset på behandling.
English: Approximately 70-80% of the administered dose is excreted within 48-72 h with the majority of the dose excreted unchanged.
Danish: Ca. 70-80 % af den administrerede dosis udskilles i løbet af 48-72 timer med hovedparten af dosen udskilt uændret.
English: The safety of the veterinary medicinal product has not been established in dogs under 9 months of age and in dogs weighing less than 3.6 kg.
Danish: Sikkerheden af veterinærlægemidlet er ikke blevet fastlagt hos hunde, der er under 9 måneder gamle, og hos hunde, der vejer mindre end 3,6 kg.
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 30 °C.
English: Administer this veterinary medicinal product on an empty stomach (e.g. in the morning) and at least one hour before the next meal, once daily at a target dose of 2 mg per kg body weight.
Danish: Administrér dette veterinærlægemiddel på en tom mave (f.eks. om morgenen) og mindst én time før det næste måltid én gang dagligt med en måldosis på 2 mg pr. kg legemsvægt.
English: The veterinary medicinal product is available in the following pack sizes:
Danish: Veterinærlægemidlet findes i følgende pakningsstørrrelser:
English: Grapiprant does not accumulate in the dog after repeated administration.
Danish: Grapiprant akkumuleres ikke i hunden efter gentagen administration.
English: Wash hands after handling of the veterinary medicinal product.
Danish: Vask hænder efter håndtering af veterinærlægemidlet.
English: The pharmacological activity of the metabolites is not known.
Danish: Den farmakologiske aktivitet af metabolitterne er ikke kendt.
English: In case of overdose, symptomatic treatment should be initiated.
Danish: I tilfælde af en overdosis skal der iværksættes symptomatisk behandling.
English: Grapiprant is a methylbenzenesulfonamide.
Danish: Grapiprant er et methylbenzensulfonamid.
English: Faecal excretion accounted for roughly 65% of the dose whereas approximately 20% of the dose was excreted through urine.
Danish: Udskillelse via afføring udgjorde ca. 65 % af dosen, hvorimod ca. 20 % af dosen blev udskilt via urin.
English: Drug compatibility should be monitored in animals requiring adjunctive therapy.
Danish: Lægemiddelforenelighed bør overvåges hos dyr, der har brug for supplerende behandling.
English: If no clinical improvement is apparent after 14 days, treatment with Galliprant should be discontinued and different treatment options should be explored in consultation with the veterinarian.
Danish: Hvis der ikke ses nogen klinisk forbedring efter 14 dage, bør behandling med Galliprant afbrydes, og andre behandlingsmuligheder bør undersøges i samråd med dyrlægen.
English: As field studies were limited to 28 days, longer-term treatment should be considered carefully and regular monitoring undertaken by the veterinarian.
Danish: Da feltstudier var begrænset til 28 dage, bør langtidsbehandling overvejes nøje, og dyrlægen bør foretage regelmæssig overvågning.
English: EU/2/17/221/001 (20 mg, 7 tablets, 20 ml bottle) EU/2/17/221/002 (20 mg, 30 tablets, 20 ml bottle) EU/2/17/221/003 (60 mg, 7 tablets, 20 ml bottle) EU/2/17/221/004 (60 mg, 30 tablets, 35 ml bottle) EU/2/17/221/005 (100 mg, 7 tablets, 35 ml bottle) EU/2/17/221/006 (100 mg, 30 tablets, 60 ml bottle)
Danish: EU/2/17/221/001 (20 mg, 7 tabletter, 20 ml beholder) EU/2/17/221/002 (20 mg, 30 tabletter, 20 ml beholder) EU/2/17/221/003 (60 mg, 7 tabletter, 20 ml beholder) EU/2/17/221/004 (60 mg, 30 tabletter, 35 ml beholder) EU/2/17/221/005 (100 mg, 7 tabletter, 35 ml beholder) EU/2/17/221/006 (100 mg, 30 tabletter, 60 ml beholder)
English: Maximum grapiprant concentrations are observed in serum within one hour of dosing in the fasted state.
Danish: Maksimale koncentrationer af grapiprant observeres i serum i løbet af én time efter dosering i fastende tilstand.
English: The tablet can be divided into equal halves.
Danish: Tabletten kan deles i to lige store dele.
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: Mild decreases in serum albumin and total protein, most often within the reference range, have been observed in dogs treated with grapiprant but were not associated with any clinically significant observations or events.
Danish: Der er observeret lette fald i serumalbumin og total protein, hyppigst inden for referenceområdet, hos hunde behandlet med grapiprant, men de var ikke forbundet med klinisk signifikante observationer eller hændelser.
English: The majority of clinical cases assessed in the clinical field studies suffered from mild to moderate osteoarthritis based on the veterinary assessment.
Danish: Størstedelen af de kliniske tilfælde, der blev vurderet i de kliniske feltstudier, led af let til moderat osteoarthritis baseret på en dyrlægevurdering.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS One tablet contains:
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Én tablet indeholder:
English: The concurrent use of grapiprant with other anti-inflammatory agents has not been studied and should be avoided.
Danish: Anvendelse af grapiprant sammen med andre antiinflammatoriske midler er ikke blevet undersøgt og bør undgås.