FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use in breeding, pregnant or lactating bitches.
Danish: Anvend ikke produktet på avlstæver, drægtige eller diegivende tæver.
English: Cimalgex 80 mg cimicoxib 80 mg For the full list of excipients see section 6.1.
Danish: Cimalgex 80 mg cimicoxib 80 mg Alle hjælpestoffer er anført under pkt.
English: Cimalgex 8 mg, tablets: oblong, white to pale brown, chewable tablets with 1 break-line on both sides.The tablets can be divided into equal halves.
Danish: Cimalgex 8 mg, tabletter: aflange, hvide til lysebrune, tyggetabletter med 1 delekærv på begge sider.
English: Blister packs - Any remaining divided tablets should be stored in the blisters but discarded if not used within 2 days.
Danish: Blisterpakninger - Tilbageværende delte tyggetabletter skal bortkastes efter 2 dages opbevaring i blisterpakningen.
English: Do not use in breeding, pregnant and lactating animals.
Danish: Bør ikke anvendes til avlstæver, under drægtighed og laktation.
English: Cimalgex 8 mg tablets for dogs Cimalgex 30 mg tablets for dogs Cimalgex 80 mg tablets for dogs cimicoxib
Danish: Cimalgex 8 mg tabletter til hunde Cimalgex 30 mg tabletter til hunde Cimalgex 80 mg tabletter til hunde cimicoxib
English: Do not use if the dog is hypersensitive to cimicoxib or any of the other ingredients in the product.
Danish: Bør ikke anvendes i tilfæde af overfølsomhed over for cimicoxib eller et eller flere af hjælpestofferne.
English: Bottles - Any remaining divided tablets should be stored in the bottle but discarded if not used within 90 days.
Danish: Tabletbeholderen - Tilbageværende delte tyggetabletter skal bortkastes efter 90 dages opbevaring i tabletbeholderen.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Cimalgex 8 mg chewable tablets for dogs Cimalgex 30 mg chewable tablets for dogs Cimalgex 80 mg chewable tablets for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Cimalgex 8 mg tyggetabletter til hund Cimalgex 30 mg tyggetabletter til hund Cimalgex 80 mg tyggetabletter til hund
English: PACKAGE LEAFLET Cimalgex 8 mg chewable tablets for dogs Cimalgex 30 mg chewable tablets for dogs Cimalgex 80 mg chewable tablets for dogs
Danish: INDLÆGSSEDDEL TIL: Cimalgex 8 mg tyggetabletter til hunde Cimalgex 30 mg tyggetabletter til hunde Cimalgex 80 mg tyggetabletter til hunde
English: References
Danish: Referencer
English: The review looked at data from several studies including:
Danish: Gennemgangen omfattede data fra flere forskellige undersøgelser, herunder:
English: More about the safety of NSAIDs
Danish: Mere om sikkerheden af NSAID
English: 22 May 2015 EMA/325007/2015
Danish: maj 2015 EMA/325007/2015
English: The review of ibuprofen was initiated on 9 June 2014 at the request of the UK's medicines agency (MHRA), under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af ibuprofen blev indledt den 9. juni 2014 på anmodning af Det Forenede Kongeriges lægemiddelstyrelse (MHRA) i medfør af artikel 31 i direktiv 2001/83/EF.
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Danish: Tlf. +44 0 20 3660 8427 E-mail: press@ema.europa.eu
English: Dexibuprofen, the active enantiomer, is sometimes available on its own and is therefore included in this review.
Danish: Dexibuprofen, den aktive enantiomer, fås undertiden særskilt og er derfor omfattet af denne gennemgang.
English: The usual dose for adults and children over 12 years of age is 200 to 400 mg, 3 or 4 times a day as needed.
Danish: Den sædvanlige dosis til voksne og børn over 12 år er 200-400 mg 3-4 gange dagligt efter behov.
English: It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Danish: Den har ansvar for harmonisering af sikkerhedsnormerne i EU for lægemidler, der godkendes ved nationale procedurer.
English: The safety of NSAIDs, including ibuprofen, has been reviewed regularly by authorities in the EU over the past few years.
Danish: Sikkerheden af NSAID, herunder ibuprofen, er jævnligt blevet gennemgået af myndighederne i EU i løbet af de senere år.
English: The review was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Danish: Gennemgangen blev foretaget af Udvalget For Risikovurdering inden for Lægemiddelvurdering (PRAC), som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som fremsatte et sæt anbefalinger.
English: The review covered formulations for systemic use (intended to act on the whole body, such as use by mouth or by injection); it did not cover formulations such as gels or sprays applied to the skin of the affected area.
Danish: Gennemgangen omfattede formuleringer til hele kroppen, dvs. til indtagelse gennem munden eller ved injektion (systemiske formuleringer); den omfattede ikke formuleringer såsom geler eller sprayer, der påføres på huden i det berørte område.
English: • The effect of duration of ibuprofen treatment on cardiovascular risk is uncertain.
Danish: • Effekten af ibuprofenbehandlingens varighed på den kardiovaskulære risiko er usikker.
English: They are available on prescription and over the counter.
Danish: De fås på recept og i håndkøb.
English: No clinically relevant effect is considered to be likely for occasional ibuprofen use.
Danish: Der forventes ingen klinisk relevant effekt ved lejlighedsvis brug af ibuprofen.
English: Risk factors include smoking, high blood pressure, diabetes and high blood cholesterol.
Danish: Til risikofaktorerne hører rygning, højt blodtryk, sukkersyge og højt kolesteroltal.
English: Reviews carried out in 2005, 2006, and 2012 confirmed that NSAIDs as a class are associated with a small increase in the risk of arterial thromboembolic events (blood clots in the arteries) especially in patients with underlying heart or circulatory conditions or with certain cardiovascular risk factors, and particularly if used at high doses.
Danish: Gennemgange foretaget i 2005, 2006 og 2012 bekræftede, at NSAID som klasse er forbundet med risiko for blodpropper i arterierne (tromboemboliske arterielle hændelser), navnlig hos patienter med underliggende hjerte- eller kredsløbssygdom eller visse hjerte-karrisikofaktorer, og navnlig i høje doser.
English: For diclofenac, the risk was estimated at around three additional major vascular events per 1,000 participants per year.
Danish: For diclofenac blev risikoen vurderet til at svare til omkring tre ekstra tilfælde af større vaskulære hændelser pr. 1 000 deltagere pr. år.
English: Ibuprofen is present in medicines as a mixture of two molecules that are enantiomers (mirror images of each other).
Danish: Ibuprofen findes i lægemidlerne som en blanding af to molekyler, der er spejlbilleder af hinanden (enantiomerer).
English: It works by blocking an enzyme called cyclooxygenase, which produces prostaglandins, substances that are involved in inflammation and pain.
Danish: Det virker ved at blokere enzymet cyclooxygenase, der anvendes ved produktion af prostaglandiner, som er medvirkende ved inflammation og smerter.
English: Ibuprofen and dexibuprofen are currently available in the European Union (EU) in a number of different formulations.
Danish: Ibuprofen og dexibuprofen markedsføres i EU i en række forskellige formuleringer.
English: A class warning of this risk is already in place and the product information for all NSAIDs, including ibuprofen, recommends that these medicines be used at the lowest effective dose and for the shortest period of time necessary to control symptoms.
Danish: Der er i forvejen indført en klasseadvarsel, og produktinformationen for alle NSAID anbefaler, at de anvendes i den laveste effektive dosis og i den kortest mulige tid, der er nødvendig til kontrol af symptomerne.
English: • Experimental data suggest long-term use of ibuprofen/dexibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid (typically 75 mg per day).
Danish: • Eksperimentelle data tyder på, at langvarig brug af ibuprofen/dexibuprofen kan nedsætte den kardioprotektive virkning af lavdosis-acetylsalicylsyre (typisk 75 mg dagligt).
English: For diclofenac, the risk was estimated at about 3 extra cases of heart attack in every 1,000 patients taking diclofenac for a year.
Danish: For diclofenac blev risikoen vurderet til at svare til 3 ekstra hjerteanfald for hver 1 000 patienter, der får diclofenac i et år.
English: This is because ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are used concomitantly.
Danish: Dette skyldes, at ibuprofen kompetitivt kan hæmme virkningen af lavdosis-acetylsalicylsyre på trombocytaggregationen, når de anvendes samtidigt.
English: The CMDh1 has endorsed by consensus updated advice on the use of high-dose ibuprofen.
Danish: CMDh1 har enstemmigt vedtaget opdaterede retningslinjer for anvendelse af høje doser ibuprofen.
English: Ibuprofen and dexibuprofen medicines have been authorised in the EU through national approval procedures and have been available for many years under a wide range of trade names.
Danish: Lægemidler med ibuprofen og dexibuprofen har været godkendt ved nationale procedurer i EU og har været på markedet i mange år under mange forskellige handelsnavne.
English: A dose of 2,400 mg per day of ibuprofen is equivalent to 1,200 mg per day of dexibuprofen.
Danish: En dosis på 2 400 mg ibuprofen dagligt svarer til 1 200 mg dexibuprofen dagligt.
English: In addition, doctors should carefully assess a patient's risk factors for heart or circulatory conditions before initiating long-term treatment with ibuprofen, particularly if high doses are required.
Danish: Desuden bør lægen nøje vurdere risikofaktorer for hjerte-karsygdomme hos patienter, der sættes i langtidsbehandling med ibuprofen, navnlig når der behøves høje doser.
English: However, it remains uncertain whether longterm use of ibuprofen in clinical practice reduces the benefits of low-dose aspirin in preventing heart attacks and strokes.
Danish: Det er dog fortsat usikkert, om langvarig brug af ibuprofen i klinisk praksis nedsætter fordelene ved lavdosis-acetylsalicylsyre til forebyggelse af hjerteanfald og slagtilfælde.
English: As the CMDh has now agreed the PRAC advice by consensus, changes to the product information for ibuprofen- and dexibuprofen-containing medicines will be implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Danish: Da CMDh nu har vedtaget PRAC's retningslinjer enstemmigt, skal ændringerne af produktinformationen for lægemidler indeholdende ibuprofen og dexibuprofen i henhold til en vedtagen tidsplan gennemføres direkte af de medlemsstater, hvor lægemidlerne er godkendt.
English: Laboratory studies have shown that ibuprofen reduces the blood-thinning effects of aspirin.
Danish: Laboratorieundersøgelser har vist, at ibuprofen nedsætter den blodfortyndende virkning af acetylsalicylsyre.
English: • Your doctor will carefully assess you before starting treatment with high-dose ibuprofen to check if you have risk factors such as high blood pressure, high blood cholesterol, diabetes, or if you smoke.
Danish: • Før du bliver sat i behandling med ibuprofen i høj dosis, vil lægen nøje vurdere, om du har risikofaktorer såsom højt blodtryk, højt kolesterolindhold i blodet eller rygning.
English: • High doses of ibuprofen should be avoided in patients with cardiovascular conditions (e.g. uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischaemic heart disease, peripheral arterial disease and cerebrovascular disease).
Danish: • Høje doser ibuprofen bør undgås hos patienter med kardiovaskulær sygdom (f.eks. ukontrolleret hypertension, kongestiv hjerteinsufficiens (NYHA klasse II-III), manifest iskæmisk hjertesygdom, perifer arteriel sygdom og cerebrovaskulær sygdom).
English: Ibuprofen is a painkiller and anti-inflammatory medicine that belongs to the class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Danish: Ibuprofen er et smertestillende og antiinflammatorisk lægemiddel, der tilhører lægemiddelklassen NSAID (nonsteroide antiinflammatoriske lægemidler).
English: Updated advice on use of high-dose ibuprofen
Danish: Ajourførte retningslinjer for brug af ibuprofen i høje doser
English: To minimise the cardiovascular risk, high doses of ibuprofen (2,400 mg per day or higher) should be avoided in patients with serious underlying heart or circulatory conditions, such as heart failure, heart disease and circulatory problems or in those who have previously had a heart attack or stroke.
Danish: For at minimere den kardiovaskulære risiko bør ibuprofen i høj dosering (2 400 mg dagligt eller derover) undgås ved alvorlige underliggende hjerte eller kredsløbsproblemer såsom hjertesvigt, hjertesygdom og kredsløbsproblemer og hos patienter med tidligere hjerteanfald eller slagtilfælde.
English: No risk has been seen with ibuprofen at doses up to 1,200 mg per day, which is the highest dose usually taken by the majority of patients.
Danish: Der er ikke konstateret risiko med ibuprofen i doser op til 1 200 mg dagligt, som er den sædvanlige højeste dosis for størstedelen af patienterne.
English: • Patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus and smoking) should only be treated with high-dose ibuprofen after careful consideration.
Danish: • Ved risikofaktorer for kardiovaskulære hændelser (f.eks. hypertension, hyperlipidæmi, diabetes mellitus eller rygning) bør høje doser ibuprofen kun anvendes efter nøje vurdering.
English: • Use of high-dose ibuprofen is no longer recommended if you have heart or circulatory conditions, such as heart failure, heart disease and circulatory problems or if you have previously had a heart attack or stroke.
Danish: • Det frarådes nu at bruge høje doser ibuprofen, hvis man har hjerte- eller kredsløbssygdomme såsom hjertesvigt, hjertesygdom og kredsløbsproblemer, eller tidligere har haft et hjerteanfald eller slagtilfælde.
English: Occasional use of ibuprofen should not affect the benefits of low-dose aspirin.
Danish: Lejlighedsvis brug af ibuprofen skulle ikke have betydning for fordelene ved lavdosis-acetylsalicylsyre.
English: The updated advice on the cardiovascular risk of high-dose ibuprofen will be included in the product information of ibuprofen medicines, along with information on the interaction between ibuprofen and aspirin.
Danish: De ajourførte retningslinjer vedrørende hjerte-karrisiko med ibuprofen i høj dosis skal indgå i produktinformationen for ibuprofen-lægemidler, ligeledes oplysninger om vekselvirkningen mellem ibuprofen og acetylsalicylsyre.
English: As ibuprofen medicines are all authorised nationally, the PRAC recommendations were forwarded to the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh), which adopted a final position.
Danish: Derfor blev anbefalingerne fra PRAC forelagt koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - lægemidler til mennesker (CMDh), som vedtog et endeligt standpunkt.
English: • If you have any questions, speak with your doctor or pharmacist.
Danish: • Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: The review also looked at data on the interaction between ibuprofen and low-dose aspirin when the latter is taken to reduce the risk of heart attacks and strokes.
Danish: Gennemgangen omfattede også vekselvirkningen mellem ibuprofen og lavdosis-acetylsalicylsyre, når dette tages for at nedsætte risikoen for hjerteanfald og slagtilfælde.
English: It followed concerns that high doses of ibuprofen could have a similar cardiovascular risk to that of COX-2 inhibitors and diclofenac.
Danish: Den var foranlediget af betænkeligheder ved, at høje doser ibuprofen kan tænkes at have samme kardiovaskulære risiko som COX-2 hæmmere og diclofenac.
English: • Data from meta-analyses and epidemiological studies indicate that there is an increased risk of cardiovascular events (such as myocardial infarction or stroke) associated with the use of highdose ibuprofen (at or above 2,400 mg per day).1-4
Danish: • Data fra metaanalyser og epidemiologiske undersøgelser viser øget risiko for kardiovaskulære hændelser (såsom myokardieinfarkt og apopleksi) ved brug af ibuprofen i høje doser (2 400 mg dagligt eller derover).1-4
English: • Prolonged use of ibuprofen may reduce the effect of low-dose aspirin when the latter is taken to reduce the risk of heart attacks and strokes.
Danish: • Langvarig brug af ibuprofen kan nedsætte virkningen af lavdosis-acetylsalicylsyre, som tages for at nedsætte risikoen for hjerteanfald og slagtilfælde.
English: • An EU-wide review of ibuprofen has confirmed that there is a small risk of heart attacks and strokes in patients taking high doses of the medicine (at or above 2,400 mg per day).
Danish: • En gennemgang af ibuprofen i EU har bekræftet, at der er en lille risiko for hjerteanfald og slagtilfælde hos patienter, der får høje doser af lægemidlet (2 400 mg dagligt eller derover).
English: • The risk with high-dose ibuprofen is similar to the risk seen with some other non-steroidal antiinflammatory drugs (NSAIDs), including COX-2 inhibitors and diclofenac.
Danish: • Risikoen ved høje doser ibuprofen svarer til den, der ses med visse andre non-steroide antiinflammatoriske lægemidler (NSAID), herunder COX-2 hæmmere og diclofenac.
English: This follows a review carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed a small increased risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen (at or above 2,400 mg per day).
Danish: Dette følger efter en gennemgang foretaget af EMA's Udvalg for Risikovurdering inden for Lægemiddelvurdering (PRAC), som fastslog en let forhøjet risiko for hjerte-karproblemer såsom hjerteanfald og slagtilfælde ved brug af ibuprofen i høje doser (2 400 mg dagligt eller derover).
English: This latest review considered accumulated evidence which clarifies the cardiovascular risk related to ibuprofen taken at high doses and the interaction between ibuprofen at any dose and aspirin.
Danish: Denne seneste gennemgang omfattede de akkumulerede erfaringer vedrørende hjerte-kar-risikoen med ibuprofen i høje doser og vekselvirkning mellem ibuprofen i alle doser og acetylsalicylsyre.
English: No increase in cardiovascular risk is seen with ibuprofen at doses of up to 1,200 mg per day, which is the highest dose generally used for over-the-counter (OTC) preparations taken by mouth in the European Union (EU).
Danish: Der er ikke øget hjerte-kar-risiko med ibuprofen i doser op til 1 200 mg dagligt, som er den højeste normale dosis for håndkøbspræparater i EU til indtagelse gennem munden.
English: The review clarifies that the risk with highdose ibuprofen is similar to the risk seen with some other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors and diclofenac.
Danish: Gennemgangen viser, at høje doser ibuprofen giver samme risiko som visse andre non-steroide antiinflammatoriske lægemidler (NSAID), herunder COX-2 hæmmere og diclofenac.
English: • Although no specific data about the cardiovascular risk with dexibuprofen are available, a similar cardiovascular risk to that with high-dose of ibuprofen is expected when dexibuprofen is used at equipotent doses (at or above 1,200 mg per day).
Danish: • For dexibuprofen foreligger der ikke specifikke data om den kardiovaskulære risiko, men dexibuprofen i ækvipotente doser (1 200 mg dagligt eller derover) må forventes at medføre samme kardiovaskulære risiko som højdosis ibuprofen.
English: Long-term cardiovascular risk of nonsteroidal antiinflammatory drug use according to time passed after first-time myocardial infarction: a nationwide cohort study.
Danish: Olsen AM, Fosbol EL, Lindhardsen J, et al. Long-term cardiovascular risk of nonsteroidal antiinflammatory drug use according to time passed after first-time myocardial infarction: a nationwide cohort study.
English: You should therefore always seek the advice of your doctor or pharmacist before using ibuprofen with aspirin.
Danish: Før du bruger ibuprofen sammen med acetylsalicylsyre, skal du derfor altid spørge lægen eller apotekspersonalet til råds.
English: Review confirms small cardiovascular risk with daily doses at or above 2,400 mg
Danish: En gennemgang fastslår, at daglige doser på 2 400 mg og derover er forbundet med en lille hjerte-karrisiko
English: On 20 May 2015 the CMDh adopted its position by consensus, therefore the advice recommended by the PRAC will be implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Danish: De foranstaltninger, der anbefales af PRAC, skal derfor nu gennemføres direkte af de medlemsstater, hvor lægemidlerne er godkendt.
English: This summary was last updated in 05-2009.
Danish: Dette sammendrag blev sidst ajourført i 05-2009.
English: Other information about Nimvastid:
Danish: Andre oplysninger om Nimvastid:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nimvastid to KRKA,d.d., Novo mesto on 11 May 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nimvastid til KRKA,d.d., Novo mesto den 11. maj 2009.
English: The Committee recommended that Nimvastid be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Nimvastid.
English: It is available as capsules (yellow: 1.5 mg, orange: 3 mg, brownish red: 4.5 mg, and brownish red and orange: 6 mg) and as white orodispersible tablets (1.5 mg, 3 mg, 4.5 mg, and 6 mg).
Danish: Det fås som kapsler (gule: 1,5 mg, orange: 3 mg, rødbrun: 4,5 mg, og rødbrun og orange: 6 mg) og som hvide smeltetabletter (1,5 mg, 3 mg, 4.5 mg, og 6 mg).
English: The full EPAR for Nimvastid can be found here.
Danish: Den fuldstændige EPAR for Nimvastid findes her.
English: This means that Nimvastid is similar to a ‘reference medicine' already authorised in the European Union (EU) called Exelon.
Danish: Det betyder, at Nimvastid er identisk med et ”referencelægemiddel”, der allerede er godkendt i Den Europæiske Union (EU), og som hedder Exelon.
English: What are the benefit and risk of Nimvastid?
Danish: Hvilken fordel og risiko er der forbundet med Nimvastid?
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NIMVASTID EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) NIMVASTID EPAR - sammendrag for offentligheden
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Nimvastid has been shown to have comparable quality and to be bioequivalent to Exelon.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Nimvastid i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Exelon.
English: Nimvastid is a ‘generic medicine'.
Danish: Nimvastid er et 'generisk lægemiddel'.
English: The starting dose for Nimvastid is 1.5 mg twice a day.
Danish: Startdosis for Nimvastid er 1,5 mg to gange dagligt.
English: Nimvastid should be given twice a day, with morning and evening meals.
Danish: Nimvastid skal gives to gange dagligt sammen med morgen- og aftensmåltidet.
English: Nimvastid is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Danish: Nimvastid anvendes til behandling af patienter med let til middelsvær Alzheimers sygdom, en fremadskridende hjernesygdom, der gradvis angriber hukommelse, intellektuelle evner og adfærd.
English: Nimvastid is a medicine that contains the active substance rivastigmine.
Danish: Nimvastid er et lægemiddel, der indeholder det aktive stof rivastigmin.