FrancophonIA/ELRC3.0 huggingface dataset:
English: Suspension for injection in pre-filled pen 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine
Danish: Injektionsvæske, suspension i cylinderampul 30% opløselig insulin aspart og 70% protaminkrystalliseret insulin aspart
English: ► There are no restrictions on treatment with NovoMix 50 during breast-feeding.
Danish: ► Der er ingen begrænsninger for behandling med NovoMix 50 ved amning.
English: ► NovoMix 50 FlexPen is only suitable for injecting under the skin.
Danish: ► NovoMix 50 FlexPen er kun egnet til indsprøjtning under huden.
English: MARKETING AUTHORISATION NUMBERS EU/1/00/142/017 1 cartridge of 3 ml EU/1/00/142/018 5 cartridges of 3 ml EU/1/00/142/019 10 cartridges of 3 ml
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/00/142/017 1 cylinderampul med 3 ml EU/1/00/142/018 5 cylinderampuller med 3 ml EU/1/00/142/019 10 cylinderampuller med 3 ml
English: NovoMix 30 FlexPen is only suitable for injecting under the skin.
Danish: NovoMix 30 FlexPen er kun egnet til indsprøjtning under huden.
English: NovoMix 70 Penfill is only suitable for injecting under the skin using a reusable pen.
Danish: NovoMix 70 Penfill er kun egnet til indsprøjtning under huden ved hjælp af en genanvendelig pen.
English: NovoMix 50 FlexPen is only suitable for injecting under the skin.
Danish: NovoMix 50 FlexPen er kun egnet til indsprøjtning under huden.
English: Do not use the cartridge if the resuspended insulin does not look uniformly white, cloudy and aqueous.
Danish: Anvend ikke cylinderampullen hvis det opblandede insulin ikke fremstår ensartet hvidt, uklart og vandigt.
English: ► NovoMix 30 FlexPen is only suitable for injecting under the skin.
Danish: ► NovoMix 30 FlexPen er kun egnet til indsprøjtning under huden.
English: ► NovoMix 70 Penfill is only suitable for injecting under the skin using a reusable pen.
Danish: ► NovoMix 70 Penfill er kun egnet til indsprøjtning under huden ved hjælp af en genanvendelig pen.
English: Check with your doctor, nurse or pharmacist if you are not sure.
Danish: • Spørg lægen, sygeplejersken eller apotekspersonalet, hvis der er mere, du vil vide.
English: NovoMix 70 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Danish: NovoMix 70 Penfill er beregnet til at blive brugt med Novo Nordisks insulindispenseringssystemer og NovoFine eller NovoTwist nåle.
English: NovoMix 50 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Danish: NovoMix 50 Penfill er beregnet til at blive brugt med Novo Nordisk insulindispenseringssystemer og NovoFine eller NovoTwist nåle.
English: NovoMix 30 Penfill is only suitable for injecting under the skin using a reusable pen.
Danish: NovoMix 30 Penfill er kun egnet til indsprøjtning under huden ved hjælp af en genanvendelig pen.
English: ► There are no restrictions on treatment with NovoMix 30 during breast-feeding.
Danish: ► Der er ingen begrænsninger for behandling med NovoMix 30 ved amning.
English: NovoMix 30 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Danish: NovoMix 30 Penfill er beregnet til at blive brugt med Novo Nordisk insulindispenseringssystemer og NovoFine eller NovoTwist nåle.
English: Before opening: NovoMix 70 FlexPen that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Danish: Før ibrugtagning: NovoMix 70 FlexPen, som ikke er i brug, skal opbevares i køleskab ved 2°C til 8°C, ikke for tæt på køleelementet.
English: During use or when carried as a spare: NovoMix 70 Penfill that is being used or carried as a spare should not be kept in the refrigerator.
Danish: Efter ibrugtagning eller medbragt som reserve: NovoMix 70 Penfill, som er taget i brug, eller som medbringes som reserve, skal ikke opbevares i køleskab.
English: During use or when carried as a spare: NovoMix 70 FlexPen that is being used or carried as a spare should not be kept in the refrigerator.
Danish: Efter ibrugtagning eller medbragt som reserve: NovoMix 70 FlexPen, som er taget i brug, eller som medbringes som reserve, skal ikke opbevares i køleskab.
English: 1 ml of the suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 30/70 (equivalent to 3.5 mg).
Danish: 1 ml suspension indeholder 100 enheder opløseligt insulin aspart*/protaminkrystalliseret insulin aspart* i forholdet 30/70 (svarende til 3,5 mg).
English: 1 ml of the suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 70/30 (equivalent to 3.5 mg).
Danish: 1 ml suspension indeholder 100 enheder opløseligt insulin aspart*/protaminkrystalliseret insulin aspart* i forholdet 70/30 (svarende til 3,5 mg).
English: ► NovoMix 50 Penfill is only suitable for injecting under the skin using a reusable pen.
Danish: ► NovoMix 50 Penfill er kun egnet til indsprøjtning under huden ved hjælp af en genanvendelig pen.
English: NovoMix 50 Penfill is only suitable for injecting under the skin using a reusable pen.
Danish: NovoMix 50 Penfill er kun egnet til indsprøjtning under huden ved hjælp af en genanvendelig pen.
English: ► NovoMix 70 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Danish: ► NovoMix 70 Penfill cylinderampuller er beregnet til anvendelse sammen med Novo Nordisk insulindispenseringssystemer og NovoFine eller NovoTwist nåle.
English: ► NovoMix 30 Penfill is only suitable for injecting under the skin using a reusable pen.
Danish: ► NovoMix 30 Penfill er kun egnet til indsprøjtning under huden ved hjælp af en genanvendelig pen.
English: NovoMix 70 FlexPen 100 units/ml suspension for injection in a pre-filled pen 70% soluble insulin aspart and 30% insulin aspart crystallised with protamine
Danish: NovoMix 70 FlexPen 100 enheder/ml injektionsvæske, suspension i en fyldt pen 70% opløseligt insulin aspart og 30% protaminkrystalliseret insulin aspart
English: Before opening: Store in a refrigerator (2°C-8°C).
Danish: Før ibrugtagning: Opbevares i køleskab (2°C-8°C), ikke for tæt på køleelementet.
English: During use or when carried as a spare: NovoMix 30 Penfill that is being used or carried as a spare should not be kept in the refrigerator.
Danish: Efter ibrugtagning eller medbragt som reserve: NovoMix 30 Penfill, som er taget i brug, eller som medbringes som reserve, skal ikke opbevares i køleskab.
English: During use or when carried as a spare: NovoMix 50 FlexPen that is being used or carried as a spare should not be kept in the refrigerator.
Danish: Efter ibrugtagning eller medbragt som reserve: NovoMix 50 FlexPen, som er taget i brug, eller som medbringes som reserve, skal ikke opbevares i køleskab.
English: Before opening: NovoMix 50 FlexPen that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Danish: Før ibrugtagning: NovoMix 50 FlexPen, som ikke er i brug, skal opbevares i køleskab ved 2°C til 8°C, ikke for tæt på køleelementet.
English: NAME OF THE MEDICINAL PRODUCT NovoMix 70 Penfill 100 units/ml suspension for injection in cartridge NovoMix 70 FlexPen 100 units/ml suspension for injection in pre-filled pen
Danish: NovoMix 70 FlexPen 100 enheder/ml, injektionsvæske, suspension i fyldt pen.
English: Before opening: NovoMix 30 FlexPen that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Danish: Før ibrugtagning: NovoMix 30 FlexPen, som ikke er i brug, skal opbevares i køleskab ved 2°C til 8°C, ikke for tæt på køleelementet.
English: Before opening: NovoMix 70 Penfill that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Danish: Før ibrugtagning: NovoMix 70 Penfill, som ikke er i brug, skal opbevares i køleskab ved 2°C til 8°C ikke for tæt på køleelementerne.
English: NovoMix 30 FlexPen 100 units/ml suspension for injection in a pre-filled pen 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine
Danish: NovoMix 30 FlexPen 100 enheder/ml injektionsvæske, suspension i en fyldt pen 30% opløseligt insulin aspart og 70% protaminkrystalliseret insulin aspart
English: During use or when carried as a spare: NovoMix 30 FlexPen that is being used or carried as a spare should not be kept in the refrigerator.
Danish: Efter ibrugtagning eller medbragt som reserve: NovoMix 30 FlexPen, som er taget i brug, eller som medbringes som reserve, skal ikke opbevares i køleskab.
English: ► NovoMix 50 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Danish: ► NovoMix 50 Penfill cylinderampuller er beregnet til anvendelse sammen med Novo Nordisk insulindispenseringssystemer og NovoFine eller NovoTwist nåle.
English: During use or when carried as a spare: NovoMix 50 Penfill that is being used or carried as a spare should not be kept in the refrigerator.
Danish: Efter ibrugtagning eller medbragt som reserve: NovoMix 50 Penfill, som er taget i brug, eller som medbringes som reserve, skal ikke opbevares i køleskab.
English: ► NovoMix 30 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Danish: ► NovoMix 30 Penfill cylinderampuller er beregnet til anvendelse sammen med Novo Nordisk insulindispenseringssystemer og NovoFine eller NovoTwist nåle.
English: I Keeping the needle upwards, press the push-button all the way in.
Danish: I Hold nålen opad og tryk trykknappen helt i bund, hvorved dosisvælgeren vender tilbage til 0.
English: NAME OF THE MEDICINAL PRODUCT NovoMix 50 Penfill 100 units/ml suspension for injection in cartridge NovoMix 50 FlexPen 100 units/ml suspension for injection in pre-filled pen
Danish: NovoMix 50 Penfill 100 enheder/ml, injektionsvæske, suspension i cylinderampul.
English: Before opening: NovoMix 30 Penfill that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Danish: Før ibrugtagning: NovoMix 30 Penfill, som ikke er i brug, skal opbevares i køleskab ved 2°C til 8°C ikke for tæt på køleelementet.
English: How to handle NovoMix 30 FlexPen
Danish: Sådan bruger du NovoMix 30 FlexPen
English: Drinking alcohol and taking NovoMix 30
Danish: Brug af NovoMix 30 sammen med alkohol
English: How to handle NovoMix 70 FlexPen
Danish: Sådan bruger du NovoMix 70 FlexPen
English: Before opening: NovoMix 50 Penfill that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Danish: Før ibrugtagning: NovoMix 50 Penfill, som ikke er i brug, skal opbevares i køleskab ved 2°C til 8°C ikke for tæt på køleelementet.
English: Drinking alcohol and taking NovoMix 50
Danish: Brug af NovoMix 50 sammen med alkohol
English: NovoMix 30 Penfill 100 units/ml suspension for injection in a cartridge 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine
Danish: NovoMix 30 Penfill 100 enheder/ml injektionsvæske, suspension i en cylinderampul 30% opløseligt insulin aspart og 70% protaminkrystalliseret insulin aspart
English: How to handle NovoMix 50 FlexPen
Danish: Sådan bruger du NovoMix 50 FlexPen
English: If they do not disappear, see your doctor.
Danish: Kontakt din læge, hvis symptomerne ikke forsvinder.
English: Drinking alcohol and taking NovoMix 70
Danish: Brug af NovoMix 70 sammen med alkohol
English: Package leaflet: Information for the user NovoMix 70 Penfill 100 units/ml suspension for injection in a cartridge 70% soluble insulin aspart and 30% insulin aspart crystallised with protamine
Danish: NovoMix 70 Penfill 100 enheder/ml injektionsvæske, suspension i en cylinderampul 70% opløseligt insulin aspart og 30% protaminkrystalliseret insulin aspart
English: 1 ml suspension contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 50/50 (equivalent to 3.5 mg).
Danish: ANGIVELSE AF AKTIVE STOFFER/AKTIVE STOFFER 1 ml suspension indeholder 100 enheder opløselig insulin aspart/protaminkrystalliseret insulin aspart i forholdet 50/50 (svarende til 3,5 mg).
English: 15 April 2014 EMA/235924/2014
Danish: Den 15. april 2014 EMA/235924/2014
English: The review of Protelos/Osseor was initiated in May 2013 at the request of European Commission under Article 20 of Regulation (EC) No 726/2004.
Danish: Gennemgangen af Protelos/Osseor blev indledt i maj 2013 på anmodning af Europa-Kommissionen i medfør af artikel 20 i forordning (EF) nr. 726/2004.
English: Importantly, the company is required to conduct further research to demonstrate the effectiveness of the new measures.
Danish: Det er desuden vigtigt, at virksomheden får pålæg om at foretage yderligere undersøgelser til påvisning af effektiviteten af de nye foranstaltninger.
English: The results showed an increased risk of myocardial infarction with Protelos/Osseor as compared with placebo (1.7% versus 1.1 %), with a relative risk of 1.6 (95% CI, 1.07 to 2.38), and an increased risk of venous thrombotic and embolic events - 1.9% versus 1.3 % with a relative risk of 1.5 (95% CI, 1.04 to 2.19).
Danish: Resultaterne viste øget risiko for myokardieinfarkt med Protelos/Osseor i forhold til placebo (1,7 % mod 1,1 %) med en relativ risiko på 1,6 (95 % SI [1,07; 2,38]) samt øget risiko for venøse tromboemboliske hændelser - 1,9 % mod 1,3 % med en relativ risiko på 1,5 (95 % SI [1,04; 2,19]).
English: Protelos/Osseor to remain available but with further restrictions
Danish: Protelos/Osseor vil fortsat kunne fås, men med yderligere begrænsninger
English: The patient's risk of developing cardiovascular disease should be evaluated before starting treatment and on a regular basis thereafter, generally every 6 to 12 months;
Danish: Patientens risiko for at udvikle kardiovaskulær sygdom bør vurderes før påbegyndelse af behandlingen og derefter regelmæssigt, i almindelighed hver 6.-12. måned.
English: In addition, patients treated with Protelos/Osseor should be screened and monitored regularly, every 6 to 12 months.
Danish: Desuden bør patienter i behandling med Protelos/Osseor screenes og regelmæssigt overvåges hver 6.-12. måned.
English: 'The CHMP agreed with the PRAC's overall assessment of the risks of Protelos/Osseor.
Danish: “CHMP tilsluttede sig PRAC's samlede vurdering af risiciene ved Protelos/Osseor.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom should remain an option for patients with no history of cardiovascular disease who cannot take other medicines.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom en behandlingsmulighed for patienter, der ikke tidligere har haft hjertekarsygdom og ikke kan få andre lægemidler.
English: • Before starting treatment, your doctor will assess your risk of heart disease and high blood pressure and continue to check your risk at regular intervals during treatment.
Danish: • Før påbegyndelse af behandlingen vil lægen vurdere din risiko for hjertesygdom og forhøjet blodtryk, og i løbet af behandlingen vil lægen kontrollere denne risiko med regelmæssige mellemrum.
English: The current recommendations add to EMA recommendations made in April 2013 not to use Protelos/Osseor in patients with known circulatory problems.
Danish: De nuværende anbefalinger slutter sig til EMA's anbefalinger fra april 2013 om ikke at anvende Protelos/Osseor til patienter med kendte kredsløbsproblemer.
English: Additional risk minimisation measures include providing educational material to prescribers to ensure that only the appropriate patients are treated with the medicine.
Danish: Som yderligere risikominimeringsforanstaltning skal der udleveres oplysningsmateriale til de ordinerende læger for at sikre, at kun egnede patienter behandles med lægemidlet.
English: This final EMA recommendation on the use of Protelos/Osseor was based on an analysis of pooled data from randomised studies in around 7,500 post-menopausal women with osteoporosis.
Danish: Den endelige anbefaling fra EMA for anvendelse af Protelos/Osseor var baseret på analyse af poolede data fra randomiserede undersøgelser hos ca. 7 500 postmenopausale kvinder med osteoporose.
English: 'The PRAC will continue to monitor the safety of Protelos /Osseor and the effectiveness of risk minimisation in long term use.'
Danish: “PRAC vil fortsat overvåge, at Protelos/Osseor er sikkert, og at risiciene ved langvarig anvendelse er effektivt minimeret.”
English: 'The PRAC has worked closely with the CHMP throughout the procedure and while we acknowledge that the recommendations of the two committees differed, our understanding of the medicine's benefit-risk profile is closely aligned and we share a common view of the importance of effective monitoring of cardiovascular risk', said June Raine, chair of the PRAC.
Danish: “PRAC har under hele proceduren arbejdet tæt sammen med CHMP, og skønt vi vedgår, at anbefalingerne fra de to udvalg af forskellige, ligger vores opfattelse af forholdet mellem fordele og risiko for lægemidlet tæt op ad hinanden, og vi har samme syn på vigtigheden af effektiv overvågning af hjerte-kar-risikoen”, sagde June Raine, formand for PRAC.
English: These final recommendations from the Agency's Committee for Medicinal Products for Human Use (CHMP) come after initial advice from the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend the medicine due to its cardiovascular risk.
Danish: Disse endelige anbefalinger fra agenturets Udvalg for Lægemidler til Mennesker (CHMP) følger efter, at Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC) indledningsvis tilrådede suspendering af lægemidlet på grund af dets hjerte-kar-risiko.
English: The first stage of this 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: Den første fase af denne gennemgang blev forestået af Udvalget For Risikovurdering inden for Lægemiddelvurdering (PRAC), som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende humanmedicinske lægemidler, og som fremsatte et sæt anbefalinger.
English: The CHMP opinion was forwarded to the European Commission, which endorsed it and issued a final legally binding decision valid throughout the EU on 15 April 2014.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som godkendte den og den 15. april 2014 vedtog en endelig beslutning med gyldighed i hele EU.
English: In deciding on how Protelos/Osseor should be used, the CHMP took into account the PRAC's analysis of its benefits and risks as well as advice from osteoporosis experts that there is a group of patients who could benefit from the medicine.
Danish: Ved fastlæggelsen af, hvordan Protelos/Osseor bør anvendes, tog CHMP hensyn til PRAC's analyse af dets fordele og risici samt råd fra eksperter i knogleskørhed om, at der er en gruppe patienter, som kan have fordel af lægemidlet.
English: The CHMP's recommendations were sent to the European Commission, which endorsed them and issued a final legally binding decision valid throughout the EU.
Danish: CHMP's anbefalinger blev overgivet til Europa-Kommissionen, som godkendte dem og traf en endelig bindende beslutning med gyldighed i hele EU.
English: In addition these patients should continue to be evaluated regularly by their doctor and treatment should be stopped if patients develop heart or circulatory problems, such as uncontrolled high blood pressure or angina.
Danish: Disse patienter skal desuden regelmæssigt vurderes af lægen, og behandlingen standses, hvis der opstår hjerte-karproblemer såsom ukontrolleret forhøjet blodtryk eller hjertekrampe.
English: Both committees worked in close collaboration and the PRAC's recommendation was instrumental for us to fully assess the benefit-risk profile of the medicine', said Tomas Salmonson, chair of the CHMP.
Danish: De to udvalg arbejdede tæt sammen, og PRAC's anbefaling var for os et redskab til udtømmende vurdering af lægemidlets benefit/risk-forhold, sagde Tomas Salmonson, formand for CHMP.
English: The PRAC's recommendations were then sent to the Committee for Medicinal Products for Human Use (CHMP) responsible for all questions concerning medicines for human use, which adopted the Agency's final opinion.
Danish: PRAC's anbefalinger blev overgivet til Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse.
English: • You should not take Protelos/Osseor if you have or have had heart or circulatory problems such as stroke, heart attack, or obstruction of the blood flow in the arteries.
Danish: • Du skal ikke bruge Protelos/Osseor, hvis du har eller har haft hjerte-karproblemer såsom slagtilfælde, hjerteanfald eller nedsat blodgennemstrømning i arterierne.
English: It is also used to treat severe osteoporosis in men who are at high risk of fracture.
Danish: Det anvendes desuden til behandling af svær knogleskørhed hos mænd med høj risiko for knoglebrud.
English: 'However, the CHMP considered that, for patients who have no alternative treatment, regular screening and monitoring to exclude cardiovascular disease will sufficiently reduce the risk identified by the PRAC so that these patients can continue to have access to the medicine.'
Danish: “CHMP fandt dog, at regelmæssig screening og overvågning til udelukkelse af hjerte-kar-sygdom vil medføre tilstrækkelig reduktion af de risici, PRAC har påpeget, så patienter uden behandlingsalternativ fortsat har mulighed for at få lægemidlet.”
English: Regarding the benefits, the efficacy data showed an effect in preventing fractures, including in patients at high risk of fracture.
Danish: Hvad fordelene angår, viste dataene effekt i form af frakturforebyggelse også hos patienter med høj frakturrisiko.
English: • Doctors should review their patients currently on Protelos/Osseor as necessary.
Danish: • Patienter, der på nuværende tidspunkt er i behandling med Protelos/Osseor, bør gennemgås i fornødent omfang.
English: The European Medicines Agency has concluded its review of Protelos/Osseor and has recommended further restricting the use of the medicine to patients who cannot be treated with other medicines approved for osteoporosis.
Danish: Det Europæiske Lægemiddelagentur har foretaget en gennemgang af Protelos/Osseor og anbefalet yderligere begrænsninger for anvendelsen hos patienter, der ikke kan behandles med andre godkendte lægemidler mod knogleskørhed.
English: • If you have any questions, speak to your doctor or pharmacist.
Danish: • Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: • Doctors should continue to base their decision to prescribe Protelos/Osseor on an assessment of the individual patient's risks.
Danish: • Beslutningen om ordinering af Protelos/Osseor bør fortsat baseres på en individuel vurdering af risikoen.
English: • Protelos/Osseor should only be used to treat severe osteoporosis in postmenopausal women and men at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance;
Danish: • Protelos/Osseor bør kun anvendes til behandling af svær osteoporose hos postmenopausale kvinder og mænd med høj frakturrisiko, når der på grund af f.eks. kontraindikationer eller intolerans ikke kan anvendes andre lægemidler, der er godkendt til behandling af osteoporose.
English: Available data do not show evidence of an increased cardiovascular risk in patients without established, current or past history of ischaemic heart disease, peripheral arterial disease or cerebrovascular disease, or in those without uncontrolled hypertension.
Danish: De foreliggende data giver ikke evidens for øget kardiovaskulær risiko hos patienter uden manifest nuværende eller tidligere iskæmisk hjertesygdom, perifer arteriel sygdom eller cerebrovaskulær sygdom eller med ukontrolleret hypertension.