FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies have been carried out to prove that Meloxidyl is ‘bioequivalent' to the reference veterinary medicinal product: this means that Meloxidyl is equivalent to Metacam in the way it is absorbed and used by the body.
Danish: Der er gennemført undersøgelser for at dokumentere, at Meloxidyl er ”bioækvivalent” med referenceveterinærlægemidlet: Det betyder, at Meloxidyl svarer til Metacam med hensyn til den måde, hvorpå det optages og anvendes i kroppen.
English: If this happens, seek medical advice immediately and show the package leaflet or the label to the doctor.
Danish: Ved utilsigtet selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: In dogs and cats the side effects seen with Meloxidyl are similar to those seen with other NSAIDs and occur only occasionally.
Danish: Hos hunde og katte svarer bivirkningerne ved Meloxidyl til de kendte bivirkninger ved andre NSAID'er og kan lejlighedsvist forekomme.
English: What is the risk associated with Meloxidyl?
Danish: Hvilken risiko er der forbundet med Meloxidyl?
English: Why has Meloxidyl been approved?
Danish: Hvorfor blev Meloxidyl godkendt?
English: Because of this, Meloxidyl's benefit is taken as being the same as that of the reference medicinal product.
Danish: Derfor anses fordelene ved Meloxidyl for at være de samme som referencelægemidlets.
English: Based on the findings of the study, Meloxidyl was considered to be bioequivalent to the reference medicinal product.
Danish: På grundlag af undersøgelsesresultaterne blev Meloxidyl anset for at være bioækvivalent med referencelægemidlet.
English: Therefore the CVMP's view was that, as for Metacam, Meloxidyl's benefits are greater than its risks.
Danish: CVMP var derfor af den opfattelse, at fordelene ved Meloxidyl, ligesom Metacam, opvejer risiciene.
English: What is Meloxidyl?
Danish: Hvad er Meloxidyl?
English: In cattle Meloxidyl injection is used to reduce clinical signs in case of acute respiratory infection with appropriate antibiotic therapy, to reduce clinical signs in case of diarrhoea in combination with oral re-hydration therapy in calves over one week of age and young, nonlactating cattle and as supportive therapy in the treatment of acute mastitis, in combination with antibiotics.
Danish: Hos kvæg anvendes Meloxidyl som injektion mod akutte luftvejsinfektioner i kombination med relevant antibiotikabehandling for at reducere kliniske tegn, mod diarré i kombination med oral rehydreringsbehandling for at reducere kliniske tegn hos kalve, der er mere en én uge gamle, og hos ungt, ikke-diegivende kvæg samt som støtteterapi ved behandling af akut mastitis, i kombination med antibiotika.
English: What is Meloxidyl used for?
Danish: Hvad anvendes Meloxidyl til?
English: In pigs Meloxidyl injection is used to reduce the symptoms of lameness and inflammation in non-infectious locomotor disorders and for supportive therapy in the treatment of puerperal septicaemia and toxaemia around farrowing (mastitis-metritis-agalactia syndrome) with appropriate antibiotics.
Danish: Hos svin anvendes Meloxidyl som injektion for at mindske symptomerne på halten og betændelse ved ikke-smittefarlige sygdomme i bevægeapparatet og som støtteterapi ved behandling af puerperal septikæmi og toksæmi i faringstiden (MMA-syndrom (mastitismetritis-agalactia)) i kombination med relevant antibiotikabehandling.
English: How has Meloxidyl been studied?
Danish: Hvordan blev Meloxidyl undersøgt?
English: In cats, Meloxidyl is used as an oral suspension to relieve inflammation and pain in chronic musculo-skeletal disorders as well as to relieve mild to moderate pain after an operation, such as spaying or soft tissue surgery.
Danish: Hos katte anvendes Meloxidyl som en oral suspension til at lindre betændelse og smerter ved kroniske lidelser i bevægeapparatet samt til at lindre milde til moderate smerter efter en operation, såsom kastreringsoperationer eller kirurgiske indgreb i blødt væv.
English: In horses Meloxidyl injection is used to relieve inflammation and pain in both acute and chronic musculo-skeletal disorders and for the relief of pain associated with colic.
Danish: Hos heste anvendes Meloxidyl som injektion for at lindre betændelse og smerter ved både akutte og kroniske lidelser i bevægeapparatet samt til smertelindring i forbindelse med kolik.
English: As an injection, Meloxidyl is also used to reduce the pain and inflammation after an operation, such as orthopaedic or soft tissue surgery.
Danish: Meloxidyl gives også som injektion for at mindske smerter og betændelse efter en operation, såsom ortopædisk kirurgi og kirurgi i blødt væv.
English: What benefit has Meloxidyl shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Meloxidyl?
English: Meloxidyl injection is used in cats to reduce the pain after an operation, such as spaying or minor soft tissue surgery.
Danish: Hos katte anvendes Meloxidyl som injektion til at lindre smerter efter en operation, såsom kastreringsoperationer eller mindre kirurgiske indgreb i blødt væv.
English: How does Meloxidyl work?
Danish: Hvordan virker Meloxidyl?
English: In dogs, Meloxidyl is used as an oral suspension to relieve inflammation and pain in musculoskeletal disorders.
Danish: Meloxidyl anvendes til lindring af betændelse og smerter ved lidelser i bevægeapparatet hos hunde.
English: Therefore, possible reduction in absorption cannot be excluded.
Danish: Derfor kan mulig reduktion i absorption ikke udelukkes.
English: ATC code: V03A E02.
Danish: ATC-kode: V03A E02.
English: Date of first authorisation: 10 June 2009 Date of latest renewal: 20 February 2019
Danish: Dato for første markedsføringstilladelse: 10. juni 2009 Dato for seneste fornyelse: 20. februar 2019
English: Appropriate symptomatic treatment should be provided.
Danish: Der bør gives passende symptomatisk behandling.
English: • being sick frequently
Danish: • hvis du ofte er syg
English: o The remaining powder may be used within 24 hours for the next dose.
Danish: o Det resterende pulver kan bruges inden for 24 timer til den næste dosis.
English: The potential risk to humans is unknown.
Danish: Den potentielle risiko for mennesker er ukendt.
English: Therefore it is currently not recommended for use in these patients.
Danish: Derfor kan det for øjeblikket ikke anbefales til brug hos disse patienter.
English: Your doctor will advise you if you are taking these medicines.
Danish: Lægen vil rådgive dig, hvis du tager disse lægemidler.
English: However the potential absorption and accumulation of sevelamer during long-term chronic treatment (> one year) cannot be totally excluded.
Danish: Imidlertid kan den potentielle absorption og akkumulering af sevelamer under langvarig kronisk behandling (> et år) ikke udelukkes fuldstændigt.
English: Frequency is not known (frequency cannot be estimated from the available data).
Danish: Frekvensen er ikke kendt (frekvensen kan ikke estimeres ud fra de tilgængelige data).
English: Use in children and adolescents
Danish: Brug hos børn og unge
English: In general, the safety profile for children and adolescents (6 to 18 years of age) is similar to the safety profile for adults.
Danish: Generelt stemmer sikkerhedsprofilen for børn og unge (6 til 18 år) overens med sikkerhedsprofilen for voksne.
English: The decrease in cholesterol has been observed after 2 weeks of treatment and is maintained with long-term treatment.
Danish: Reduktionen af kolesterol er blevet observeret efter 2 ugers behandling og vedligeholdt med langtidsbehandling.
English: Elderly population No dosage adjustment is necessary in the elderly population.
Danish: Ældre Dosisjustering er ikke nødvendig hos ældre.
English: >0.75 to <1.2
Danish: > 0,75 til < 1,2
English: Renvela should be taken with food and not on an empty stomach.
Danish: Renvela skal tages sammen med mad og ikke på tom mave.
English: Follow the diet prescribed by your doctor.
Danish: Følg den diæt, din læge har ordineret.
English: Frequency is not known.
Danish: Frekvensen er ikke kendt.
English: It is recommended that vitamin supplements be given if necessary.
Danish: Det anbefales at give vitamintilskud efter behov.
English: Therefore this medicine is not recommended for use in children below the age of 6 years.
Danish: Derfor anbefales dette lægemiddel ikke til børn under 6 år.
English: Digoxin, warfarin, enalapril or metoprolol
Danish: Digoxin, warfarin, enalapril eller metoprolol
English: Take Renvela after your meal or with food.
Danish: Tag Renvela efter eller sammen med din mad.
English: Sevelamer carbonate is not absorbed and may affect the bioavailability of other medicinal products.
Danish: Sevelamercarbonat absorberes ikke og kan påvirke biotilgængeligheden af andre lægemidler.
English: If the therapy is initiated, patients suffering from these disorders should be monitored.
Danish: Hvis behandlingen påbegyndes, skal patienter med disse sygdomme overvåges.
English: This information was obtained from studies in which sevelamer hydrochloride was used.
Danish: Denne information stammer fra studier, i hvilke sevelamerhydrochlorid blev anvendt.
English: This is a very rare side effect (may affect up to 1 in 10,000 people).
Danish: Dette er en meget sjælden bivirkning (kan påvirke op til 1 ud af 10.000 personer).
English: No new risks or safety signals were identified with the use of sevelamer carbonate during the study.
Danish: Der blev ikke identificeret nye risici eller sikkerhedssignaler ved brug af sevelamercarbonat under studiet.
English: Tablets must be swallowed whole.
Danish: Tabletterne skal synkes hele.
English: • Renvela should not be taken at the same time as ciprofloxacin (an antibiotic).
Danish: • Renvela må ikke tages på samme tid som ciprofloxacin (antibiotikum).
English: Titration increases/decreases
Danish: Titrering forøgelse/reduktion
English: o Close the sachet by folding over twice.
Danish: o Luk brevet ved at folde det to gange.
English: It is important to drink all of the liquid to ensure that all of the powder is swallowed.
Danish: Det er vigtigt at drikke al væsken, for at sikre, at alt pulveret er slugt.
English: Bioavailability
Danish: Biotilgængelighed
English: Genzyme Ireland Limited IDA Industrial Park Old Kilmeaden Road Waterford
Danish: IDA Industrial Park Old Kilmeaden Road Waterford
English: 27% of paediatric patients reached their age appropriate serum phosphorus level at end of treatment.
Danish: 27 % af pædiatriske patienter nåede deres aldersrelaterede serumfosfatniveau ved behandlingens afslutning.
English: The potential risk of Renvela during human pregnancy is unknown.
Danish: Den mulige risiko ved at tage Renvela under graviditet er ukendt.
English: If you have missed one dose, this dose should be omitted and the next dose should be taken at the usual time with a meal.
Danish: Hvis du har glemt en dosis, skal du springe den over og tage næste dosis til sædvanlig tid sammen med et måltid.
English: Not data are available.
Danish: Der foreligger ingen data.
English: Additional treatments Due to either your kidney condition or your dialysis treatment you may:
Danish: Øvrige behandlinger: På grund af enten din nyresygdom eller din dialysebehandling kan følgende gælde for dig:
English: MedDRA System Organ Class
Danish: MedDRA Systemorganklasser
English: Discard sachets of powder that have been opened for more than 24 hours.
Danish: o Bortskaf breve med pulver, der har været åbne i mere end 24 timer.
English: Titration and maintenance *Adults
Danish: Titrering og vedligeholdelse *Voksne
English: Adverse reactions that occurred during clinical trials or that were spontaneously reported from postmarketing experience are listed by frequency in the table below.
Danish: Bivirkninger, som opstod under de kliniske studier, eller som blev spontant indberettet efter markedsføring, er angivet efter hyppighed i skemaet nedenfor.
English: The exact starting dose and regimen will be determined by your doctor.
Danish: Den nøjagtige startdosis og behandlingsplan fastsættes af din læge.
English: The effects may be secondary to vitamin D depletion.
Danish: Virkningerne kan være sekundære i forhold til D-vitamindepletering.
English: Most of these adverse reactions were mild to moderate in intensity.
Danish: De fleste af disse bivirkningers sværhedsgrad var mild til moderat.
English: These figures were 23% and 15% in the subgroup of patients on hemodialysis and peritoneal dialysis, respectively.
Danish: Disse tal var 23 % og 15 % i undergrupperne af patienter i henholdsvis hæmodialyse og peritonealdialyse.
English: • you have low levels of phosphate in your blood (your doctor will check this for you)
Danish: • hvis du har et lavt indhold af fosfat i blodet (lægen måler dette)
English: Constipation may be a preceding symptom.
Danish: Obstipation kan være et første symptom.
English: It cannot be excluded that sevelamer carbonate can bind fat-soluble vitamins contained in ingested food.
Danish: Det kan ikke udelukkes, at sevelamercarbonat kan binde fedtopløselige vitaminer i indtaget mad.
English: • adult patients on dialysis (a blood clearance technique).
Danish: • voksne patienter i dialyse (en blodrensningsteknik).
English: There are no or limited amount of data from the use of sevelamer in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af sevelamer til gravide.
English: Renvela must be taken three times per day with meals.
Danish: Renvela skal tages tre gange dagligt sammen med måltider.
English: Intestinal obstruction and ileus/subileus
Danish: Intestinal obstruktion og ileus/subileus
English: Constipation is a very common side effect (may affect more than 1 in 10 people).
Danish: Forstoppelse er en meget almindelig bivirkning (kan påvirke flere end 1 ud af 10 personer).
English: There is at present insufficient data to exclude the possibility of folate deficiency during long term sevelamer carbonate treatment.
Danish: Der er p.t. utilstrækkelige data til at udelukke risikoen for folatmangel under langtidsbehandling med sevelamercarbonat.
English: These deposits can stiffen your blood vessels and make it harder for blood to be pumped around the body.
Danish: Aflejringerne kan gøre dine blodkar stive og gøre det mere besværligt for blodet at blive pumpet rundt i kroppen.
English: Consequently, sevelamer carbonate should not be taken simultaneously with ciprofloxacin.
Danish: Derfor bør sevelamercarbonat ikke tages samtidigt med ciprofloxacin.
English: Since this medicine does not contain calcium your doctor might prescribe additional calcium tablets.
Danish: Eftersom dette lægemiddel ikke indeholder kalk, kan lægen ordinere et kalktilskud i form af tabletter.
English: The most frequently occurring (≥ 5% of patients) adverse reactions were all in the gastrointestinal disorders system organ class.
Danish: De hyppigst forekommende (≥ 5 % af patienterne) bivirkninger var alle i systemorganklassen mave-tarmkanalen.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation holder.
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: It is important to drink all of the liquid and it may be necessary to rinse the glass with water and drink this as well to ensure that all of the powder is swallowed.
Danish: Det er vigtigt at drikke det hele og det kan være nødvendigt at fylde lidt mere vand i det tomme glas og drik også det for at være sikker på, at du har slugt alt pulveret.
English: Non-clinical data with sevelamer reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or genotoxicity.
Danish: Non-kliniske data med sevelamer viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser eller genotoksicitet.
English: • problems with motility (movement) in your stomach and bowel
Danish: • hvis du har problemer med motiliteten (bevægeligheden) i maven og tarmene
English: This medicine should not be given on an empty stomach and should be taken with meals or snacks.
Danish: Dette lægemiddel skal ikke gives på tom mave, men tages sammen med måltider eller mellemmåltider.
English: • you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for det aktive stof eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Patients on peritoneal dialysis should be closely monitored to ensure the correct use of appropriate aseptic technique with the prompt recognition and management of any signs and symptoms associated with peritonitis.
Danish: Patienter i peritonealdialyse skal overvåges nøje for at sikre korrekt brug af aseptisk teknik samt øjeblikkelig genkendelse og håndtering af tegn og symptomer på peritonitis.
English: Dialysis Interaction studies have not been conducted in patients on dialysis.
Danish: Dialyse Der er ikke gennemført interaktionsstudier på patienter i dialyse.
English: Contact your doctor who will decide on continuing the treatment or not.
Danish: Kontakt din læge, der vil beslutte om behandlingen skal fortsættes eller ej.
English: The safety and efficacy of sevelamer carbonate have not been established in patients with the following disorders:
Danish: Sikkerheden og virkningen af sevelamercarbonat er ikke klarlagt hos patienter med følgende sygdomme:
English: A total of 101 patients (6 to 18 years old with a BSA range of 0.8 m2 to 2.4 m2) were randomised in the study.
Danish: I alt blev 101 patienter (6 til 18 år med et legemsoverfladearealinterval på 0,8 m til 2,4 m2) randomiseret i studiet.
English: Carcinogenicity studies with oral sevelamer hydrochloride were conducted in mice (doses of up to 9 g/kg/day) and rats (0.3, 1, or 3 g/kg/day).
Danish: Karcinogenicitetsstudier med oral sevelamerhydrochlorid blev udført med mus (doser på op til 9 g/kg/dag) og rotter (0,3, 1 eller 3 g/kg/dag).
English: Sevelamer has no or negligible influence on the ability to drive and use machines.
Danish: Sevelamer har ingen eller ubetydelig indflydelse på evnen til at føre motorkøretøj og betjene maskiner.
English: There are no data from the effect of sevelamer on fertility in humans.
Danish: Der er ingen data for sevelamers påvirkning af fertiliteten hos mennesker.
English: It is unknown whether Renvela is excreted in breast milk and may affect your baby.
Danish: Det vides ikke om Renvela udskilles i modermælken, og kan påvirke din baby.
English: The treatment response during the 2-week FDP was not affected by BSA, in contrast however, no treatment response was observed in paediatric patients with qualifying phosphorus levels <7.0 mg/dL.
Danish: Behandlingsresponset i den 2-ugers FDP blev ikke påvirket af legemsoverfladeareal, derimod blev der ikke observeret behandlingsrespons hos pædiatriske patienter med kvalificerende fosfatniveauer < 7,0 mg/dL.
English: • If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking Renvela.
Danish: • Hvis du tager medicin for problemer med hjerterytmen eller for epilepsi, skal du fortælle det til lægen, inden du tager Renvela.
English: Your doctor will check for interactions between Renvela and other medicines on a regular basis.
Danish: Lægen vil jævnligt kontrollere vekselvirkningen mellem Renvela og eventuel anden medicin.
English: Most of adverse events reported as related, or possibly related, to sevelamer carbonate were gastrointestinal in nature.
Danish: De fleste bivirkninger rapporteret som relateret eller eventuelt relateret til sevelamercarbonat var af gastrointestinal karakter.
English: Many of these cases involved patients with co-morbid conditions including swallowing disorders or oesophageal abnormalities.
Danish: Mange af disse tilfælde har involveret patienter med følgesygdomme, bl.a. synkeforstyrrelser eller esophagus-abnormaliteter.
English: In a clinical trial of one year, no evidence of accumulation of sevelamer was seen.
Danish: I et et-årigt klinisk studie blev der ikke set tegn på akkumulering af sevelamer.
English: In clinical trials of sevelamer, both the mean total-cholesterol and LDL-cholesterol declined by 15-39%.
Danish: I kliniske studier med sevelamer reduceredes både det gennemsnitlige total-kolesterol og LDL-kolesterol med 15-39 %.
English: The sachets are packaged in an outer carton.
Danish: Foliebrevet er pakket i en ydre karton.
English: In the clinical trials in haemodialysis patients, sevelamer alone did not have a consistent and clinically significant effect on iPTH.
Danish: I de kliniske studier med hæmodialysepatienter havde sevelamer alene ikke nogen vedvarende og klinisk signifikant virkning på iPTH.
English: Because sevelamer binds bile acids, it may interfere with the absorption of fat soluble vitamins such as A, D, E and K.
Danish: Eftersom sevelamer binder galdesyrer, kan det interferere med absorptionen af fedtopløselige vitaminer såsom A, D, E og K.
English: Tablets should be swallowed intact and should not be crushed, chewed, or broken into pieces prior to administration.
Danish: Tabletterne skal synkes hele og må ikke knuses, tygges eller brækkes i stykker inden indtagelse.
English: The recommended starting dose of Renvela for children is based on their height and weight (used to calculate body surface area by your physician).
Danish: Den anbefalede startdosis af Renvela til børn er baseret på deres højde og vægt (bruges til at beregne legemsoverfladeareal af lægen).
English: Your doctor can rather prescribe Renvela powder for oral suspension
Danish: Din læge kan ordinere Renvela pulver til oral suspension
English: The phosphate serum level should be monitored and the Renvela dosage adjusted consequently.
Danish: Fosfat-serum niveauet bør overvåges, og Renvela dosis justeret i overensstemmelse hermed.
English: Each carton contains 60 or 90 sachets.
Danish: Hver karton indeholder 60 eller 90 breve.
English: Only for bottle label of 180 tablets: PC:
Danish: Kun til tabletbeholder etiket for 180 tabletter: PC:
English: If you consider stopping your Renvela treatment, contact your doctor or pharmacist first.
Danish: Hvis du overvejer at stoppe din Renvela-behandling, skal du først kontakte din læge eller apotekspersonalet.
English: Triglycerides, HDL-cholesterol and albumin levels did not change following sevelamer treatment.
Danish: Triglycerider, HDL-kolesterol og albumin koncentrationerne forandredes ikke efter behandling med sevelamer.
English: When administering any medicinal product where a reduction in the bioavailability could have a clinically significant effect on safety or efficacy, the medicinal product should be administered at least one hour before or three hours after sevelamer carbonate, or the physician should consider monitoring blood levels.
Danish: Ved administration af et lægemiddel, hvor en reduktion af biotilgængeligheden kan have en klinisk signifikant påvirkning på sikkerheden eller virkningen, skal det pågældende lægemiddel administreres mindst en time inden eller tre timer efter sevelamercarbonat, eller lægen bør overveje at måle koncentrationerne i blodet.
English: Sevelamer carbonate is not indicated for the control of hyperparathyroidism.
Danish: Sevelamercarbonat er ikke indiceret til kontrol af hyperparathyroidisme.
English: Pharmacotherapeutic group: All other therapeutic products, drugs for treatment of hyperkalemia and hyperphosphataemia.
Danish: Farmakoterapeutisk klassifikation: Alle andre terapeutiske produkter, lægemidler til behandling af hyperkaliæmi og hyperfosfatæmi.
English: Forty-nine (49) patients received sevelamer carbonate and 51 received placebo during the 2 week FDP.
Danish: 49 patienter fik sevelamercarbonat og 51 fik placebo i løbet af de 2-ugers FDP.
English: Pharmacokinetic studies have not been carried out with sevelamer carbonate.
Danish: Der er ikke udført farmakokinetiske studier med sevelamercarbonat.
English: Thereafter all patients received sevelamer carbonate for the 26-week DTP.
Danish: Derefter fik alle patienter sevelamercarbonat i 26-ugers DTP.