FrancophonIA/ELRC3.0 huggingface dataset:
English: It is therefore recommended to monitor plasma potassium levels when using FORTEKOR PLUS in combination with a potassium sparing diuretic because of the risk of hyperkalaemia.
Danish: Det anbefales derfor at monitorere kaliumniveauer i plasma, når der anvendes FORTEKOR PLUS i kombination med et kaliumbesparende diuretikum på grund af risikoen for hyperkalæmi.
English: White and light brown oval bilayer tablets with a score line on both sides.
Danish: Hvide og lysebrune, ovale tolagstabletter med delekærv på begge sider.
English: ADVICE ON CORRECT ADMINISTRATION FORTEKOR PLUS tablets can be divided into halves if needed.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE FORTEKOR PLUS-tabletter kan om nødvendigt deles i to lige store dele.
English: It also exhibits a vasodilatory action through the inhibition of phosphodiesterase type III activity.
Danish: Det har også en vasodilaterende effekt ved at hæmme phosphodiesterase type III-aktiviteten.
English: In dogs with congestive heart failure, benazepril hydrochloride and pimobendan have been given in combination with digoxin and diuretics without demonstrable adverse interactions.
Danish: Hos hunde med kongestivt hjertesvigt er benazeprilhydrochlorid og pimobendan blevet givet sammen med digoxin og diuretika uden påviselige bivirkninger.
English: Transient reversible hypotension may occur in accidental overdose.
Danish: Forbigående reversibel hypotension kan forekomme i tilfælde af utilsigtet overdosering.
English: A moderate increase in plasma creatinine concentrations following administration of ACE inhibitors is compatible with the reduction in glomerular hypertension induced by these agents, and is therefore not necessarily a reason to stop therapy in the absence of other signs.
Danish: En moderat øgning af plasmakreatininkoncentrationerne efter administration af ACEhæmmere er forenelig med reduktionen i glomerulær hypertension forårsaget af disse midler og er derfor ikke nødvendigvis en grund til at stoppe behandlingen, hvis der ikke er andre tegn.
English: The safety of FORTEKOR PLUS has not been established in breeding, pregnant or lactating dogs.
Danish: Sikkerheden af FORTEKOR PLUS ikke blevet fastlagt i avlsdyr, drægtige eller diegivende hunde.
English: In rare cases transient diarrhoea, anorexia or lethargy have been observed.
Danish: I sjældne tilfælde er der observeret forbigående diarré, anoreksi eller letargi.
English: Transient reversible hypotension (low blood pressure) may occur in accidental overdose.
Danish: Forbigående reversibel hypotension (lavt blodtryk) kan forekomme i tilfælde af utilsigtet overdosering.
English: Lactose monohydrate Magnesium stearate
Danish: Lactosemonohydrat Magnesiumstearat Majsstivelse
English: Do not use in cases of hypertrophic cardiomyopathies or clinical conditions where an augmentation of cardiac output is not possible for functional or anatomical reasons (e.g. aortic or pulmonary stenosis).
Danish: Bør ikke anvendes i tilfælde af hypertrofisk kardiomyopati eller kliniske tilstande, hvor en forøgelse af hjertets minutvolumen umuliggøres af funktionelle eller anatomiske årsager (f.eks. aorta- eller pulmonalstenose).
English: Your veterinary surgeon may recommend to closely monitor kidney function and for signs of hypotension (lethargy, weakness etc) and treat these if necessary.
Danish: Din dyrelæge vil måske anbefale en nøje overvågning af nyrefunktionen og tegn på lavt blodtryk (letargi, svaghed osv.) og om nødvendigt behandle disse symptomer.
English: After the oral administration of FORTEKOR PLUS tablets at twice the recommended dose to dogs, peak levels of both compounds are attained rapidly (Tmax 0.5 h for benazepril hydrochloride and 0.85 h for pimobendan) with peak concentrations (Cmax) for benazepril hydrochloride of 35.1 ng/ml and 16.5 ng/ml for pimobendan.
Danish: Efter oral administration af FORTEKOR PLUS-tabletter med to gange den anbefalede dosis til hunde nås maksimalniveauerne for begge stoffer hurtigt (Tmax 0,5 timer for benazeprilhydrochlorid og 0,85 timer for pimobendan) med maksimale koncentrationer (Cmax) for benazeprilhydrochlorid på 35,1 ng/ml og 16,5 ng/ml for pimobendan.
English: In dogs with chronic kidney disease, benazepril may increase plasma creatinine concentrations at the start of therapy.
Danish: Hos hunde med kronisk nyrelidelse kan benazepril øge plasmakreatininkoncentrationerne i starten af behandlingen.
English: Croscarmellose sodium Crospovidone
Danish: Croscarmellosenatrium Crospovidon
English: As pimobendan is metabolised in the liver, the product should not be administered to dogs with severe hepatic insufficiency.
Danish: Da pimobendan metaboliseres i leveren, bør produktet ikke administreres til hunde med svær leverinsufficiens.
English: Laboratory studies in rats and rabbits with pimobendan have not shown any effect on fertility.
Danish: Laboratorieundersøgelser af rotter og kaniner med pimobendan har ikke vist nogen effekt på fertiliteten.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals)
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelig (flere end 1, men færre end 10 dyr ud af 100 dyr) - Ualmindelig (flere end 1, men færre end 10 dyr ud af 1.000 dyr) - Sjælden (flere end 1, men færre end 10 dyr ud af 10.000 dyr)
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelig (flere end 1, men færre end 10 dyr ud af 100 dyr) - Ualmindelig (flere end 1, men færre end 10 dyr ud af 1.000 dyr) - Sjælden (flere end 1, men færre end 10 dyr ud af 10.000 dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter).
English: Each tablet contains 5 mg pimobendan and 10 mg benazepril hydrochloride.
Danish: Hver tablet indeholder 5 mg pimobendan og 10 mg benazeprilhydrochlorid.
English: 26 Rue de la Chapelle F-68330 Huningue
Danish: Fremstiller ansvarlig for batchfrigivelse: Elanco France S.A.S 26 Rue de la Chapelle F-68330 Huningue
English: Use during pregnancy, lactation:
Danish: Brug under dræftighed, diegivning:
English: The combination of FORTEKOR PLUS and other anti-hypertensive agents (e.g. calcium channel blockers, β-blockers or diuretics), anaesthetics or sedatives may lead to additive hypotensive effects.
Danish: Kombinationen af FORTEKOR PLUS og andre anti-hypertensive midler (f.eks. calciumkanalblokkere, β-blokkere eller diuretika), anæstetika eller sedativer kan medføre øgede hypotensive virkninger.
English: A moderate positive chronotropic effect and vomiting may occur in rare cases.
Danish: Der kan i sjældne tilfælde forekomme en moderat positiv kronotrop effekt og opkastning.
English: Pimobendan, a benzimidazole-pyridazinone derivative, is a non-sympathomimetic, non-glycoside inotropic substance with potent vasodilating properties.
Danish: Pimobendan, et benzimidazol-pyridazinon-derivat, er en non-sympatomimetisk, non-glycosid inotrop substans med potente vasodilaterende egenskaber.
English: Do not use in cases of hypotension (low blood pressure), hypovolemia (low blood volume), hyponatraemia (low blood sodium levels) or acute renal (kidney) failure.
Danish: Må ikke anvendes i tilfælde af hypotension (lavt blodtryk), hypovolæmi (lav blodmængde), hyponatriæmi (lavt natriumindhold i blodet) eller akut nyresvigt.
English: Therefore the concurrent use of FORTEKOR PLUS with NSAIDs or any other medications with a hypotensive effect should be considered carefully before using such combinations.
Danish: Derfor bør samtidig brug af FORTEKOR PLUS og NSAID'er eller anden medicin med hypotensiv virkning overvejes nøje.
English: Laboratory studies in rats with benazepril have shown foetotoxic effects (foetal urinary tract malformation) at maternally non-toxic doses.
Danish: Laboratorieundersøgelser af rotter med benazepril har vist føtotoksiske virkninger (føtal urinvejsmisdannelse) ved doser, der ikke er maternelt toksiske.
English: Pimobendan is a non-sympathomimetic, non-glycoside inotropic substance with potent vasodilating properties.
Danish: Pimobendan er en non-sympatomimetisk, non-glycosid inotrop substans med potente vasodilaterende egenskaber.
English: The pimobendan-induced increase in contractility of the heart is attenuated in the presence of the calcium antagonist verapamil and the ß-antagonist propranolol.
Danish: Den pimobendan-inducerede forbedring af hjertets kontraktionsevne svækkes ved brug af calciumantagonisten verapamil og ß-antagonisten propranolol.
English: FORTEKOR PLUS is a combination of 2 active substances: pimobendan and benazepril hydrochloride.
Danish: Farmakodynamiske egenskaber FORTEKOR PLUS er en kombination af 2 aktive stoffer: pimobendan og benazeprilhydrochlorid.
English: Do not use in cases of hypotension, hypovolaemia, hyponatraemia or acute renal failure.
Danish: Bør ikke anvendes i tilfælde af hypotension, hypovolæmi, hyponatriæmi eller akut nyresvigt.
English: It is not known if benazepril is secreted into the milk of lactating bitches.
Danish: Det vides ikke, om benazepril udskilles i modermælken hos diegivende tæver.
English: Benazeprilat is an inhibitor of ACE, thus reducing the blood pressure and volume load on the heart in dogs with congestive heart failure.
Danish: Benazeprilat er en ACE-hæmmer og reducerer således blodtrykket og fyldningsgraden af hjertet hos hunde med kongestivt hjertesvigt.
English: Benazepril increased the time to worsening of heart failure, and the time to death, improved clinical condition, reduced cough and improved exercise tolerance in dogs with symptomatic congestive heart failure caused by valvular disease or dilated cardiomyopathy.
Danish: Benazepril øgede tiden til forværring af hjertesvigt og tiden til død, forbedrede den kliniske tilstand, reducerede hoste og forbedrede udholdenheden ved fysisk anstrengelse hos hunde med symptomatisk kongestivt hjertesvigt forårsaget af hjerteklapsygdom eller dilateret kardiomyopati.
English: Laboratory studies in rats have shown that pimobendan is excreted into milk.
Danish: Laboratorieundersøgelser af rotter har vist, at pimobendan udskilles i modermælk.
English: Your veterinary surgeon may therefore recommend the monitoring of plasma potassium concentrations when using FORTEKOR PLUS in combination with a potassium-sparing diuretic because of the risk of hyperkalaemia (high blood potassium).
Danish: Derfor vil din dyrlæge måske anbefale en overvågning af kaliumkoncentrationerne i blodet, når der anvendes FORTEKOR PLUS i kombination med et kaliumbesparende diuretikum på grund af risikoen for hyperkalæmi (højt indhold af kalium i blodet).
English: EU/2/15/185/001 (1 x 30 tablets, 1.25 mg/2.5 mg tablets) EU/2/15/185/002 (1 x 60 tablets, 1.25 mg/2.5 mg tablets) EU/2/15/185/003 (1 x 30 tablets, 5 mg/10 mg tablets) EU/2/15/185/004 (1 x 60 tablets, 5 mg/10 mg tablets)
Danish: EU/2/15/185/001 (1 x 30 tabletter, 1,25 mg/2,5 mg tabletter) EU/2/15/185/002 (1 x 60 tabletter, 1,25 mg/2,5 mg tabletter) EU/2/15/185/003 (1 x 30 tabletter, 5 mg/10 mg tabletter) EU/2/15/185/004 (1 x 60 tabletter, 5 mg/10 mg tabletter)
English: Silica, colloidal anhydrous Silicon dioxide anhydrous Sodium laurilsulfate Starch pregelatinised Succinic acid Sucrose
Danish: Silica, kolloid vandfri Siliciumdioxid, vandfri Natriumlaurilsulfat Prægelatiniseret stivelse Ravsyre
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each tablet contains 1.25 mg pimobendan and 2.5 mg benazepril hydrochloride.
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Hver tablet indeholder 1,25 mg pimobendan og 2,5 mg benazeprilhydrochlorid.
English: Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis.
Danish: Må ikke anvendes i tilfælde af hjertesvigt på grund af aorta- eller pulmonalstenose.
English: In dogs with congestive heart failure benazepril hydrochloride reduces the blood pressure and volume load on the heart.
Danish: Hos hunde med kongestivt hjertesvigt reducerer benazeprilhydrochlorid blodtrykket og fyldningsgraden af hjertet.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS Blister
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterpakning
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæske
English: Artificial Special Dry Flavour Basic butylated methacrylate copolymer Copovidone
Danish: Kunstigt smagsstof Butyleret methacrylatcopolymer Copovidon
English: Pimobendan is oxidatively demethylated to its major active metabolite, O-desmethyl pimobendan.
Danish: Ved oxidativ demethylering af pimobendan dannes den aktive hovedmetabolit, O-desmethyl pimobendan.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Danish: TEKSTEN “TIL DYR” Til dyr.
English: Do not use during pregnancy or lactation.
Danish: Må ikke anvendes under drægtighed eller laktation.
English: The plasma elimination half-life of pimobendan when dosed with FORTEKOR PLUS tablets is 0.5 h, consistent with the high clearance of the compound.
Danish: Efter dosering med FORTEKOR PLUS-tabletter er eliminationshalveringstiden i plasma for pimobendan 0,5 timer, hvilket stemmer overens med stoffets høje clearance.
English: Pack Sizes
Danish: Pakningsstørrelser
English: Dibutyl sebacate
Danish: Dibutylsebacat
English: Levels of benazepril decline quickly as the drug is partially metabolised by liver enzymes to benazeprilat.
Danish: Benazepril-niveauerne aftager hurtigt, eftersom stoffet delvist metaboliseres af leverenzymer til benazeprilat.
English: In cases of chronic kidney disease, it is recommended to check the dog's hydration status before starting therapy, and to monitor its plasma creatinine and blood erythrocyte counts during therapy.
Danish: I tilfælde af kronisk nyrelidelse anbefales det at kontrollere hundens hydreringstilstand, inden behandlingen påbegyndes, og at monitorere plasmakreatinin og erytrocyttal under behandlingen.
English: Benazepril hydrochloride:
Danish: Benazeprilhydrochlorid:
English: FORTEKOR PLUS 5 mg/10 mg tablets
Danish: FORTEKOR PLUS 5 mg/10 mg tabletter
English: The recommended dose range for FORTEKOR PLUS is 0.25-0.5 mg pimobendan per kg bodyweight and 0.5-1 mg benazepril hydrochloride per kg bodyweight divided into two daily doses.
Danish: Den anbefalede dosis af FORTEKOR PLUS er 0,25-0,5 mg pimobendan/kg kropsvægt og 0,5-1 mg benazeprilhydrochlorid/kg kropsvægt fordelt på to daglige doser.
English: The tablets are bilayered, oval, white and light brown, and can be divided into halves along the score line.
Danish: Tabletterne er hvide og lysebrune, ovale tolagstabletter og kan deles langs delekærven.
English: Pimobendan/Benazepril hydrochloride
Danish: Pimobendan/Benazeprilhydrochlorid
English: For the treatment of congestive heart failure due to atrioventricular valve insufficiency or dilated cardiomyopathy in dogs.
Danish: Behandling af kongestivt hjertesvigt, som skyldes atrioventrikulær klapinsufficiens eller dilateret kardiomyopati hos hunde.
English: Microcrystalline cellulose
Danish: Cellulose, mikrokrystallinsk
English: Benazepril hydrochloride is a prodrug which is hydrolysed in vivo to its active metabolite, benazeprilat.
Danish: Benazeprilhydrochlorid er et prodrug, som hydrolyseres in vivo til dets aktive metabolit, benazeprilat.
English: The plasma elimination half-life of benazepril hydrochloride and benazeprilat, when dosed with FORTEKOR PLUS tablets is 0.36 h and 8.36 h, respectively.
Danish: Efter dosering med FORTEKOR PLUS-tabletter er eliminationshalveringstiden i plasma for benazeprilhydrochlorid og benazeprilat henholdsvis 0,36 timer og 8,36 timer.
English: In humans, the combination of ACE inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs) can lead to reduced anti-hypertensive efficacy or impaired kidney function.
Danish: Hos mennesker kan kombinationen af ACE-hæmmere og non-steroide antiinflammatoriske lægemidler (NSAID'er) medføre reduceret anti-hypertensiv virkning eller svækket nyrefunktion.
English: Laboratory studies in rats and rabbits with pimobendan have shown foetotoxic effects at maternotoxic doses.
Danish: Laboratorieundersøgelser af rotter og kaniner med pimobendan har vist føtotoksiske virkninger ved maternelt toksiske doser.
English: Strength and number of tablets to be administered FORTEKOR PLUS 1.25 mg/2.5 mg tablets
Danish: Styrke og antal tabletter, der skal administreres FORTEKOR PLUS 1,25 mg/2,5 mg tabletter
English: Do not use during pregnancy and lactation (see section 4.7).
Danish: Bør ikke bruges under drægtighed og laktation (se pkt.
English: Do not use in case of hypersensitivity to pimobendan, to benazepril hydrochloride or to any ingredient of the tablets.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for pimobendan, benazeprilhydrochlorid eller over for et eller flere af indholdsstofferne i tabletterne.
English: Any remaining half tablets should be discarded after 1 day.
Danish: Halve tabletter bør anvendes inden for 24 timer.
English: FORTEKOR PLUS 1.25 mg/2.5 mg tablets
Danish: FORTEKOR PLUS 1,25 mg/2,5 mg tabletter
English: Benazepril hydrochloride
Danish: Benazeprilhydrochlorid
English: The main active metabolite of pimobendan is eliminated with a plasma elimination half-life of 2.6 h. Pimobendan is excreted principally in the faeces and to a lesser extent in the urine.
Danish: Pimobendans vigtigste aktive metabolit elimineres med en plasmaeliminationshalveringstid på 2,6 timer.
English: Benazepril hydrochloride is partially metabolised by liver enzymes to the active metabolite benazeprilat.
Danish: Benazeprilhydrochlorid metaboliseres delvist af leverenzymer til den aktive metabolit benazeprilat.
English: FORTEKOR PLUS 5 mg/10 mg tablets: 30 tablets or 60 tablets.
Danish: FORTEKOR PLUS 5 mg/10 mg tabletter: 30 tabletter eller 60 tabletter.
English: FORTEKOR PLUS 1.25 mg/2.5 mg tablets: 30 tablets or 60 tablets.
Danish: FORTEKOR PLUS 1,25 mg/2,5 mg tabletter: 30 tabletter eller 60 tabletter.
English: Any remaining half tablet should be placed back in the opened blister and stored (for a maximum of 1 day) in the original cardboard carton out of the sight and reach of children.
Danish: Halve tabletter skal lægges tilbage i den åbnede blisterpakning og opbevares (i maks.
English: 1.25 mg/2.5 mg tablets: pack sizes of 30 or 60 tablets.
Danish: 1,25 mg/2,5 mg tabletter: pakning med 30 eller 60 tabletter.
English: 5 mg/10 mg tablets: pack sizes of 30 or 60 tablets.
Danish: 5 mg/10 mg tabletter: pakning med 30 eller 60 tabletter.
English: The tablets are breakable along the score line.
Danish: Tabletterne kan deles langs delekærven.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT FORTEKOR PLUS 1.25 mg/2.5 mg tablets for dogs FORTEKOR PLUS 5 mg/10 mg tablets for dogs pimobendan/benazepril hydrochloride
Danish: VETERINÆRLÆGEMIDLETS NAVN FORTEKOR PLUS 1,25 mg/2,5 mg tabletter til hunde FORTEKOR PLUS 5 mg/10 mg tabletter til hunde pimobendan/benazeprilhydrochlorid
English: FORTEKOR PLUS 1.25 mg/2.5 mg tablets for dogs FORTEKOR PLUS 5 mg/10 mg tablets for dogs
Danish: FORTEKOR PLUS 1,25 mg/2,5 mg tabletter til hunde FORTEKOR PLUS 5 mg/10 mg tabletter til hunde
English: Elanco GmbH
Danish: Indehaver af markedsføringstilladelsen: Elanco GmbH
English: PACKAGE LEAFLET FOR: FORTEKOR PLUS 1.25 mg/2.5 mg tablets for dogs FORTEKOR PLUS 5 mg/10 mg tablets for dogs
Danish: INDLÆGSSEDDEL TIL: FORTEKOR PLUS 1,25 mg/2,5 mg tabletter til hunde FORTEKOR PLUS 5 mg/10 mg tabletter til hunde
English: NAME OF THE VETERINARY MEDICINAL PRODUCT FORTEKOR PLUS 1.25 mg/2.5 mg tablets for dogs FORTEKOR PLUS 5 mg/10 mg tablets for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN FORTEKOR PLUS 1,25 mg/2,5 mg tabletter til hunde FORTEKOR PLUS 5 mg/10 mg tabletter til hunde
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Elanco France S.A.S
Danish: FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Elanco France S.A.S 26 Rue de la Chapelle F-68330 Huningue Frankrig B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG Må kun udleveres efter veterinærrecept.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Elanco GmbHHeinz-Lohmann-Str. 4
Danish: INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Elanco GmbH
English: MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically.
Danish: Patientens behov for symptomlindring og behandlingsrespons bør evalueres med jævne mellemrum.
English: B. Package Leaflet
Danish: B. INDLÆGSSEDDEL
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Danish: Bilag III Tillæg til de relevante afsnit i produktresume og indlægsseddel
English: Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.
Danish: Patienter med væsentlige risikofaktorer for kardiovaskulære hændelser (f.eks. hypertension, hyperlipidæmi, diabetes mellitus, rygning) bør kun behandles med diclofenac efter nøje overvejelse.
English: As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Danish: Da de kardiovaskulære risici ved brug af diclofenac kan øges med dosis og behandlingsvarighed, bør den kortest mulige behandlingsvarighed og den laveste effektive daglige dosis anvendes.
English: Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Danish: Kronisk venstresidig hjerteinsufficiens (NYHA II-IV), iskæmisk hjertesygdom, perifer arteriel sygdom og/eller cerebrovaskulær sygdom.
English: If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides
Danish: • hvis De har hjertekramper (angina), blodpropper, forhøjet blodtryk, forhøjet kolesterol eller forhøjede triglycerider
English: If you have diabetes
Danish: • hvis De har sukkersyge (diabetes mellitus)
English: Section 2 ‘What you need to know before you take <diclofenac containing medicinal product> [The wording below should be inserted in the relevant sections]
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE {produkter, der indeholder diclofenac} [Nedennævnte tekst skal indsættes i det relevante afsnit]
English: Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150mg daily) and in long term treatment.
Danish: Kliniske forsøg og epidemiologiske data tyder på, at der er en øget risiko for arterielle tromboser (f.eks myokardieinfarkt og apopleksi) ved brug af diclofenac, især ved brug af høje doser (150 mg) og ved langtidsbehandling (se pkt.
English: Make sure your doctor knows, before you are given diclofenac If you smoke
Danish: Sørg for at fortælle det til lægen, før De får diclofenac: