FrancophonIA/ELRC3.0 huggingface dataset:
English: For candesartan- and valsartan-containing products, which are also authorised in the treatment of heart failure, additional information was agreed upon to reflect the fact that dual RAS blockade therapy in combination with an ACE-inhibitor may be of benefit in certain patients who cannot use other heart failure treatments, provided that they are used under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Danish: For produkter indeholdende candesartan og valsartan, der også er godkendt til behandling af hjerteinsufficiens, blev der vedtaget supplerende oplysninger om, at behandling med dobbelt RAS-blokering i kombination med end ACEhæmmere kan være til fordel for visse patienter, som ikke kan få anden behandling for hjerteinsufficiens, forudsat at det sker under opsyn af speciallæge og hyppig tæt overvågning af nyrefunktion, elektrolytter og blodtryk.
English: In particular, a number of trials in heart failure patients have shown that the addition of a second RASacting agent may reduce hospital admissions for heart failure in patients with heart failure, which is considered a meaningful clinical endpoint.
Danish: En række undersøgelser hos patienter med hjerteinsufficiens har således vist, at tillæg af endnu et RAS-aktivt stof kan reducere indlæggelser af sådanne patienter, hvilket anses for et meningsfuldt klinisk endepunkt.
English: The PRAC therefore concluded that dual RAS blockade therapy should not be routinely used in the treatment of heart failure and is not recommended in the general population although it may benefit certain patients who remain symptomatic while receiving monotherapy or who cannot otherwise use alternative therapies, including potentially patients with diabetic nephropathy.
Danish: PRAC konkluderede derfor, at dobbelt RAS-blokering ikke bør anvendes til rutinemæssig behandling af hjerteinsufficiens, og at det frarådes til den almindelige befolkning, men at det kan være til fordel for visse patienter, hos hvem symptomerne persisterer ved monoterapi, eller som ikke har andre behandlingsmuligheder, hvilket potentielt også gælder patienter med diabetisk nefropati.
English: • The PRAC reviewed the totality of the available data, including clinical trials, meta-analysis and publications, the MAHs' responses as well as the report from the Scientific Advisory Group in Cardiovascular Issues;
Danish: • PRAC gennemgik alle foreliggende data, herunder kliniske undersøgelser, metaanalyse og publikationer, besvarelserne fra markedsføringstilladelsesindehaverne samt rapporten fra den videnskabelige rådgivende gruppe vedrørende kardiovaskulære spørgsmål (SAG CVS),
English: The PRAC concluded that the benefit-risk balance of RAS-acting agents remains favourable, including in the context of dual RAS blockade therapy, subject to the agreed revisions to the product information.
Danish: PRAC konkluderede, at benefit/risk-forholdet for RAS-aktive stoffer fortsat er positivt, også i forbindelse med dobbelt RAS-blokering, under forudsætning af de vedtagne revisioner af produktinformationen.
English: The PRAC was of the opinion that the concerns identified during this procedure with regard to the safety and the lack of efficacy of dual RAS blockade therapy could be adequately managed through changes to the product information, without the need for additional risk minimisation measures.
Danish: PRAC var af den opfattelse, at de problemer, der ved proceduren var konstateret vedrørende sikkerhed og manglende virkning af dobbelt RAS-blokering, kunne håndteres tilfredsstillende gennem ændringer af produktinformationen, uden at der behøvedes yderligere risikominimeringsforanstaltninger.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of RAS-acting agents remains favourable, provided that their product information is revised to reflect the concerns associated with dual RAS blockade therapy.
Danish: konkluderede PRAC, at benefit/risk-forholdet for RAS-aktive stoffer fortsat er positivt under forudsætning af, at produktinformationen revideres med henblik på de problemer, der er forbundet med behandling med dobbelt RAS-blokering.
English: The PRAC considered that the available efficacy data indicates that dual RAS blockade therapy does not provide significant benefit in the general patient population, although there is evidence to suggest that some selected patient subpopulations may benefit from this dual RAS blockade therapy.
Danish: PRAC fandt, at de foreliggende data om virkning viser, at dobbelt RAS-blokering ikke er til nævneværdig fordel for den almindelige patientpopulation; dog tyder nogen evidens på, at visse udvalgte patientundergrupper kan have fordel af behandlingen.
English: 2 - Detailed explanation of the scientific grounds for differences from the PRAC recommendation
Danish: 2 - Detaljeret videnskabelige begrundelse for afvigelserne fra PRAC's anbefaling
English: • The PRAC considered that the available efficacy data indicates that dual RAS blockade therapy does not provide significant benefit in the general patient population although certain patient subpopulations may benefit from treatment, provided that it occurs only under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure;
Danish: • PRAC fandt, at de foreliggende data om virkning viser, at dobbelt RAS-blokering ikke er til nævneværdig fordel for den almindelige patientpopulation, men at visse delpopulationer kan have gavn af behandlingen, forudsat at denne udelukkende finder sted under opsyn af speciallæge og under tæt overvågning af nyrefunktion, elektrolytter og blodtryk,
English: • The PRAC was of the opinion that the concerns identified with regard to safety and the lack of additional efficacy of dual RAS blockade therapy are a class effect and that the conclusions of the review therefore apply to all the active substances involved in this procedure;
Danish: • PRAC anså de konstaterede sikkerhedsmæssige problemer og den manglende ekstra virkning af dobbelt RAS-blokering for en klassevirkning, hvorfor konklusionerne fra gennemgangen er gyldige for alle aktive stoffer omfattet af proceduren,
English: In particular, the publication of a meta-analysis by Makani et al1 involving over 68,000 patients raised concerns that combining several RAS-acting agents may be associated with an increased risk of hyperkalaemia, hypotension and kidney failure, compared with the single use of one RAS-acting agent.
Danish: En metaanalyse foretaget af Makani et al1 med over 68 000 patienter medførte således betænkelighed ved, at kombination af flere RAS-aktive stoffer kan tænkes at medføre større risiko for hyperkaliæmi, hypotension og nyresvigt end monoterapi med et RAS-aktivt stof.
English: • The PRAC was of the opinion that the concerns identified with regard to the safety and the lack of additional efficacy of dual RAS blockade therapy can be adequately managed through changes to the product information, without the need for additional risk minimisation measures.
Danish: • PRAC var af den opfattelse, at de konstaterede problemer vedrørende sikkerhed og manglende virkning af dobbelt RAS-blokering kan håndteres tilfredsstillende gennem ændringer af produktinformationen, uden at der behøves supplerende risikominimeringsforanstaltninger,
English: Having considered the new available evidence from the scientific literature and given the seriousness of the identified safety concerns, the Italian Medicines Agency (AIFA) decided to initiate a review under Article 31 of Council Directive 2001/83/EC on 17 April 2013, referring the matter to the Pharmacovigilance Risk Assessment Committee (PRAC) and requesting the PRAC to issue a recommendation on the benefit-risk of dual RAS blockade therapy through the combined use of ACEinhibitors, ARBs or aliskiren and whether any regulatory measures should be taken on the marketing authorisations of the products involved in this procedure.
Danish: Efter gennemgang af den foreliggende nye evidens fra den videnskabelige litteratur og på baggrund af alvorligheden af de fundne sikkerhedsproblemer indledte den italienske lægemiddelstyrelse (AIFA) en gennemgang i henhold til artikel 31 i Rådets direktiv 2001/83/EF af 17. april 2013 ved at indbringe sagen for Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC).
English: • The PRAC was of the view that there is considerable evidence, in particular from the ONTARGET, ALTITUDE and VA NEPHRON-D trials which conclusively demonstrates that dual RAS blockade therapy through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with an increased risk of adverse events, including hypotension, hyperkalaemia and renal failure compared to monotherapy;
Danish: • PRAC fandt, at der er omfattende evidens, navnlig fra ONTARGET-, ALTITUDE- og VA NEPHRON-Dundersøgelserne, der konklusivt viser, at behandling med dobbelt RAS-blokering gennem kombineret anvendelse af ACE-hæmmere, ARB eller aliskiren er forbundet med større risiko end monoterapi for bivirkninger, herunder hypotension, hyperkaliæmi og nyresvigt, navnlig hos patienter med diabetisk nefropati,
English: RAS-acting agents act by blocking different stages of the renin-angiotensin system, lowering blood pressure and their use in the treatment of hypertension and its complications (including acute myocardial infarction, congestive heart failure and chronic kidney disease) is recommended in many current clinical guidelines.
Danish: Mange gældende kliniske retningslinjer anbefaler dem til behandling af hypertension og komplikationerne heraf (herunder akut myokardieinfarkt, venstresidig hjerteinsufficiens og kronisk nyresygdom).
English: The PRAC was of the opinion that there is considerable evidence from large clinical trials and meta-analyses which conclusively demonstrates that dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren is associated with an increased risk of adverse events, including hypotension, hyperkalaemia and renal failure compared to monotherapy, in particular in patients with diabetic nephropathy.
Danish: PRAC fandt, at omfattende evidens fra store kliniske undersøgelser og metaanalyser konklusivt viser, at behandling med dobbelt RAS-blokering gennem kombineret brug af ACE-hæmmere og ARB eller aliskiren medfører større risiko end monoterapi for bivirkninger, herunder hypotension, hyperkaliæmi og
English: Annex IV Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Danish: Videnskabelige konklusioner og begrundelse for ændring af betingelserne for markedsføringstilladelserne samt detaljeret redegørelse for den videnskabelige begrundelse for afvigelserne fra anbefalingen fra PRAC (Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelvurdering)
English: Follow-up continued up to Day 77.
Danish: Follow-up fortsatte indtil dag 77.
English: Oral absorption by the child is however unlikely.
Danish: Oral absorption hos barnet er imidlertid usandsynligt.
English: Conditions you need to look out for
Danish: Tilstande du skal holde øje med
English: Sit or lie down in a comfortable position.
Danish: Sæt eller læg dig i en behagelig stilling.
English: Do not use this medicine:
Danish: Brug ikke dette lægemiddel:
English: Date of first authorisation: 21 March 2002 Date of latest renewal: 21 March 2007
Danish: Dato for første markedsføringstilladelse: 21. marts 2002 Dato for seneste fornyelse: 21. marts 2007
English: Contact a doctor immediately if you get these symptoms.
Danish: Kontakt lægen omgående, hvis du får disse symptomer.
English: The active substance is:
Danish: Det aktive stof er:
English: May cause severe allergic reactions.
Danish: Kan give alvorlige allergiske reaktioner.
English: Wash your hands thoroughly with soap and water and dry them with a towel.
Danish: Vask hænderne grundigt med vand og sæbe og tør med håndklæde.
English: Arixtra does not contain any animal products.
Danish: Arixtra indeholder ikke animalske produkter.
English: • the expiry date has not passed
Danish: • at udløbsdatoen ikke er overskredet
English: Death, MI or TVR at Day 30
Danish: Død, MI eller TVR ved dag 30
English: This is shown in Picture 3 at the beginning of these instructions.
Danish: Dette er vist i figur 3 i begyndelsen af denne vejledning.
English: • It is normal to see a small air bubble in this syringe.
Danish: • Det er helt normalt, at der er en lille luftboble i sprøjten.
English: Gender - No gender differences were observed after adjustment for body weight.
Danish: Køn - Der blev ikke observeret kønsspecifikke forskelle efter justering for legemsvægt.
English: No conclusion can be drawn with regard to clinical efficacy in this uncontrolled study.
Danish: Der kan ikke drages konklusioner om klinisk effekt i dette ukontrollerede studie.
English: This will help to reduce the discomfort at the injection site.
Danish: Dette vil mindske ubehag ved injektionsstedet.
English: The distribution volume of fondaparinux is limited (7-11 litres).
Danish: Fondaparinux fordelingsvolumen er begrænset (7-11 liter).
English: Two patients had reports of bleeding during the study.
Danish: To patienter fik blødninger under studiet.
English: This medicinal product is for single use only.
Danish: Dette lægemiddel er kun til engangsbrug.
English: The median duration of treatment in this study was 3.5 days.
Danish: I dette studie var den mediane behandlingstid 3,5 dage.
English: The mortality benefit shown in the fondaparinux group was maintained until the end of follow-up at Day 180.
Danish: Den mortalitetsgevinst, der blev observeret i fondaparinuxgruppen, blev opretholdt til slutningen af opfølgningsperioden ved dag 180.
English: • if you have a bacterial heart infection
Danish: • hvis du har en bakteriel hjerteinfektion
English: At higher doses, moderate changes in aPTT can occur.
Danish: Ved højere doser kan der forekomme moderate ændringer i aPTT.
English: Signs include:
Danish: Symptomer inkluderer:
English: The majority of events were asymptomatic distal DVT.
Danish: De fleste hændelser var asymptomatisk distal DVT.
English: If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apoteket til råds, før du tager dette lægemiddel.
English: Concomitant oral anticoagulation treatment should be initiated as soon as possible and usually within 72 hours.
Danish: Samtidig behandling med orale antikoagulantia bør indledes snarest muligt og fortrinsvis i løbet af 72 timer.
English: ATC code: B01AX05
Danish: ATC-kode: B01AX05.
English: • Arixtra does not need to be kept in the fridge.
Danish: • Arixtra behøves ikke at blive opbevaret i køleskab.
English: Clinical studies
Danish: Kliniske studier
English: • if you are bleeding excessively
Danish: • hvis du bløder kraftigt
English: Do not freeze
Danish: Må ikke nedfryses
English: Arixtra is used to:
Danish: Arixtra anvendes til:
English: Over 4,874 patients were studied in controlled Phase II and III clinical studies.
Danish: Over 4.874 patienter deltog i kliniske kontrollerede fase II- og fase III-studier.
English: Usual dose
Danish: Sædvanlig dosis
English: System organ class MedDRA
Danish: Systemorganklasse MedDRA
English: Special populations
Danish: Særlige befolkningsgrupper
English: Clean the injection area with an alcohol wipe.
Danish: Rens injektionsområdet med en spritserviet.
English: No studies on the effect on the ability to drive and to use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: However, rare spontaneous reports of aPTT prolongation have been received.
Danish: Der er dog set sjældne spontane tilfælde af aPTT-forlængelse.
English: • Subcutaneous administration
Danish: • Subkutan administration
English: The majority of patients were Hispanic (67%) and 58% were male.
Danish: Hovedparten af patienterne var latinamerikanere (67 %), og 58 % var drenge.
English: The difference in total VTE rates between the treatment groups, which was not statistically significant, was mainly due to a reduction of asymptomatic distal DVT.
Danish: Forskellen i den totale forekomst af VTE i de to grupper, som ikke var statistisk signifikant, skyldtes hovedsageligt en reduktion i asymptomatisk distal DVT.
English: • fainting or dizziness, low blood pressure
Danish: • besvimelse eller svimmelhed, lavt blodtryk
English: If administered via a minibag, the infusion should be given over 1 to 2 minutes.
Danish: Ved brug af miniposer skal infusionen gives over 1-2 minutter.
English: Treatment should be initiated as soon as possible following diagnosis and continued for up to a maximum of 8 days or until hospital discharge if that occurs earlier.
Danish: Behandlingen bør initieres så hurtigt som muligt efter diagnosen og fortsættes i op til maksimalt 8 dage, eller indtil patienten udskrives, såfremt dette sker tidligere.
English: (2) Npn stands for non-protein-nitrogen such as urea, uric acid, amino acid, etc.
Danish: 2) NPN står for nonprotein-nitrogen såsom urinstof, urinsyre, aminosyre osv.
English: You should continue Arixtra treatment for as long as your doctor has told you, since Arixtra prevents development of a serious condition.
Danish: Du skal fortsætte behandlingen lige så længe, som lægen siger, da Arixtra forebygger en alvorlig tilstand.
English: Arixtra has not been tested in children and adolescents under the age of 17 years.
Danish: Arixtra er ikke undersøgt hos børn og unge under 17 år.
English: Some other medicines may affect the way that Arixtra works or be affected by Arixtra.
Danish: Visse lægemidler kan påvirke virkningen af Arixtra eller selv blive påvirket af Arixtra.
English: Severe allergic reactions (anaphylaxis): These are very rare in people (up to 1 in 10,000) taking Arixtra.
Danish: Alvorlige allergiske reaktioner (anafylaksi): Disse er meget sjældne (kan forekomme hos op til 1 ud af 10.000) hos personer, som tager Arixtra.
English: These instructions are for both types of syringes (automatic and manual needle protection system).
Danish: Denne vejledning kan bruges til begge typer af injektionssprøjter (automatisk og manuelt beskyttelsessystem af nålen).
English: Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4) in vitro.
Danish: Fondaparinux hæmmer ikke CYP450-enzymer (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 og CYP3A4) in vitro.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, må denne medicin ikke blandes med andre lægemidler.
English: Types of safety syringe
Danish: Typer af sikkerhedssprøjter
English: • swelling, sometimes of the face or mouth (angioedema), causing difficulty in swallowing or breathing
Danish: • hævelse, nogle gange af ansigtet eller munden (angioødem), som kan gøre det svært at synke eller at trække vejret
English: The difference in mortality was statistically significant in stratum 1 (placebo comparator) but not in stratum 2 (UFH comparator).
Danish: Forskellen i mortalitet var signifikant i stratum 1 (sammenlignet med placebo) men ikke i stratum 2 (sammenlignet med UFH).
English: The incidence of symptomatic VTE, including PE was not significantly different between treatment groups.
Danish: Forekomsten af symptomatiske tromboemboliske komplikationer inklusive PE var ikke signifikant forskellig i behandlingsgrupperne.
English: Do not try to remove this air bubble before making the injection - you may lose some of the medicine if you do.
Danish: Forsøg ikke at fjerne denne luftboble før indsprøjtning - du risikerer at miste noget af medicinen.
English: Remove the syringe from the carton and check that:
Danish: Tag injektionssprøjten ud af æsken og tjek:
English: As a result, the concentration of fondaparinux is expressed as milligrams (mg).
Danish: Som følge deraf udtrykkes fondaparinux i milligram (mg).
English: Between 50 kg and 100 kg
Danish: Mellem 50 kg og 100 kg
English: For any information about this medicinal product, 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: The safety and efficacy of 1.5 mg has not been studied.
Danish: Sikkerheden og virkningen af 1,5 mg er ikke blevet undersøgt.
English: Arixtra should not be prescribed to pregnant women unless clearly necessary.
Danish: Arixtra må ikke anvendes af gravide kvinder, medmindre det er absolut nødvendigt.
English: Animal studies are insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal development because of limited exposure.
Danish: De udførte dyreforsøg er utilstrækkelige med hensyn til virkningerne for graviditetens og/eller embryoets/fostrets udvikling, fødslen og den postnatale udvikling på grund af begrænset eksponering.
English: Plasma concentrations of half the mean Cmax values are reached 25 minutes post-dosing.
Danish: Plasmakoncentrationer på halvdelen af de gennemsnitlige Cmax-værdier indtræffer 25 minutter efter indgift.
English: Race - Pharmacokinetic differences due to race have not been studied prospectively.
Danish: Race - Forskelle i farmakokinetik, som kan tilskrives race, er ikke undersøgt prospektivt.
English: Sixty-nine percent of the patients underwent surgery for cancer.
Danish: 69 % var cancerkirurgi.
English: Stop taking Arixtra.
Danish: Stop med at tage Arixtra.
English: → Tell your doctor if any of these applies to you.
Danish: → Fortæl det til lægen, hvis noget af dette gælder for dig.
English: The majority of patients (88%) achieved target fondaparinux concentrations at 4 hours after the first dose of fondaparinux.
Danish: Hovedparten af patienterne (88 %) opnåede den ønskede fondaparinuxkoncentration 4 timer efter første dosis fondaparinux.
English: Standard Dose UFH N = 1002
Danish: Standarddosis-UFH N = 1.002
English: Animal studies do not show any effect on fertility.
Danish: Dyreforsøg viser ingen tegn på påvirkning af fertiliteten.
English: Hold the syringe firmly by the finger grip.
Danish: Hold godt fast i sprøjten ved fingerstøtten.
English: One type of syringe has an automatic needle protection system and the other type has a manual needle protection system.
Danish: Den ene type sikkerhedssprøjte har et automatisk beskyttelsessystem af nålen, hvorimod den anden har et manuelt beskyttelsessystem af nålen.
English: After subcutaneous dosing, fondaparinux is completely and rapidly absorbed (absolute bioavailability 100%).
Danish: Efter subkutan indgift absorberes fondaparinux fuldstændigt og hurtigt med en absolut biotilgængelighed på 100 %.
English: Only fondaparinux can be used to calibrate the anti-Xa assay (the international standards of heparin or LMWH are not appropriate for this use).
Danish: Kun fondaparinux kan anvendes til at kalibrere en anti-Xa assay (de internationale standarder for heparin eller lavmolekylært heparin egner sig ikke til dette formål).
English: → Tell your doctor if you think any of these applies to you.
Danish: → Fortæl det til lægen, hvis du mener, at noget af dette gælder for dig.
English: Latex Allergy
Danish: Latexallergi
English: The repeated dose and reproduction toxicity studies did not reveal any special risk but did not provide adequate documentation of safety margins due to limited exposure in the animal species.
Danish: Reproduktionstoksicitet efter gentagne doser viste ingen særlig risiko, men gav ikke tilstrækkelig dokumentation for sikkerhedsmarginer på grund af begrænset eksponering i dyreforsøg.