natgillin/translations-raw huggingface dataset:
Antihypertensiva (f.eks. diuretika) og andre stoffer der kan sænke blodtrykket (f.eks. nitrater, tricykliske antidepressiva, anæstetika, akut alkoholindtag, bacloren, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin): Forstærket risiko for hypotension er forventelig (se pkt. 
Antihypertensive agents (e.g. diuretics) and other substances that may decrease blood pressure (e.g. nitrates, tricyclic antidepressants, anaesthetics, acute alcohol intake, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin): Potentiation of the risk of hypotension is to be anticipated (see section 4.2 for diuretics)
Hjerteinsufficiens: 
Heart failure:
Vanddrivende medicin såsom furosemid 
• Diuretics (water tablets) such as furosemide
I 6 lande er startdosis imidlertid 1,25 mg til 2,5 mg to gange daglig. 
However in 6 countries the starting dose is 1.25 mg to 2.5 mg twice daily.
isoproterenol, dobutamin, dopamin, epinephrin) der kan reducere den antihypertensive effekt af TRITACE: Der anbefales monitorering af blodtrykket. 
Vasopressor sympathomimetics and other substances (e.g. isoproterenol, dobutamine, dopamine, epinephrine) that may reduce the antihypertensive effect of TRITACE: Blood pressure monitoring is recommended.
Graviditet og amning 
PREGNANCY AND LACTATION
Nyrefunktionen og serumkalium bør monitoreres. Den efterfølgende dosis TRITACE bør justeres i overensstemmelse med blodtryksmålet. 
The subsequent dosage of TRITACE should be adjusted according to blood pressure target.
til patienter med hypertension medfører en nedsættelse i det liggende og stående blodtryk uden en kompenserende stigning i hjertefrekvens. 
Administration of ramipril to patients with hypertension leads to a reduction in supine and standing blood pressure without a compensatory rise in heart rate.
INFORMATION I BRAILLE SKRIFT [Udfyldes nationalt] 
INFORMATION IN BRAILLE [To be completed nationally]
Pædiatriske patienter 
Paediatric population
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
TRITACE bør opstartes gradvist med en anbefalet startdosis på 2,5 mg daglig. 
TRITACE should be started gradually with an initial recommended dose of 2.5 mg daily.
Kapsel, hård 
Capsule, hard
Patienter med stærkt aktiveret renin-angiotensin-aldosteronsystem har risiko for udtalt blodtryksfald, og forværrelse af nyrefunktionen grundet ACE-hæmning, særligt når en ACE-hæmmer eller 
- Patients with strongly activated renin-angiotensin-aldosterone system Patients with strongly activated renin-angiotensin-aldosterone system are at risk of an acute pronounced fall in blood pressure and deterioration of renal function due to ACE inhibition, especially when an ACE inhibitor or a concomitant diuretic is given for the first time or at first dose increase.
til at føre motorkøretøj eller betjene maskiner 
Driving and using machines
Vaskulære sygdomme Ortostatisk hypotension, nedsat blodtryk, synkope 
Hypotension, orthostatic blood pressure decreased, syncope
Vaskulær stenose, hyperperfusion, vaskulit 
Vascular stenosis, hypoperfusion, vasculitis
ikke foreligger understøttende data for stoffet for 24-timers intervallet efter myokardieinfarkt, vedtog CHMP følgende ordlyd: “Efter 48 timer efter myokardieinfarkt hos en klinisk og hæmodynamisk stabil patient er startdosis 2,5 mg to gange dagligt i tre dage. 
The CHMP, considered that in the absence of substance specific supportive data in this post myocardial infarction (MI) 24 hour interval, agreed the following: “After 48 hours, following myocardial infarction in a clinically and haemodynamically stable patient, the starting dose is 2.5 mg twice daily for three days.
initielle fast af behandlingen, og hos patienter med nedsat nyrefunktion, samtidig kollagen sygdom (f.eks. lupus erythematosus eller skleroderma), og for alle i behandling med andre lægemidler, der kan medføre ændringer i blodbilledet. 
More frequent monitoring is advised in the initial phase of treatment and in patients with impaired renal function, those with concomitant collagen disease (e.g. lupus erythematosus or scleroderma), and all those treated with other medicinal products that can cause changes in the blood picture (see sections 4.5 and 4.8).
CHMP vedtog således en harmoniseret formulering i overensstemmelse med arbejdsgruppen vedrørende lægemiddelovervågnings formulering omkring brugen af ACE-I under graviditet. 
In conclusions, the CHMP adopted a harmonised wording in line with PhVWP wording on use of AEC-I in pregnancy.
Øre og labyrint 
Ear and labyrinth disorders
til ramiprilat var forsinket hos patienter med nedsat leverfunktion, grundet formindsket aktivitet af leveresteraser, og således blev plasmakoncentrationen af ramipril hos disse patienter forøget. 
In patients with impaired liver function, the metabolism of ramipril to ramiprilat was delayed, due to diminished activity of hepatic esterases, and plasma ramipril levels in these patients were increased.
• Tør hoste, bihulebetændelse (sinusitis)eller bronkitis, stakåndethed 
• Dry tickly cough, inflammation of your sinuses (sinusitis) or bronchitis, shortness of breath
Der var størst uenighed med hensyn til indikationen for nyrebeskyttelse. 
The nephroprotection indication presented the major area of disagreement.
AstraZeneca Österreich GmbH Schwarzenbergplatz 7 
AstraZeneca Österreich GmbH Schwarzenbergplatz 7 A-1037 Wien
Øget blodkalium Anoreksi, nedsat appetit 
Anorexia, decreased appetite,
Efter flere doser ramipril en gang daglig er den effektive halveringstid af ramiprilatkoncentrationerne 13-17 timer for 5-10 mg doser, og endnu længere for 1,25-2,5 mg doser. Denne forskel relateres til den mættelige kapacitet af enzymets binding til ramiprilat. 
After multiple once-daily doses of ramipril, the effective half-life of ramiprilat concentrations was 1317 hours for the 5-10 mg doses and longer for the lower 1.25-2.5 mg doses.
Den daglige dosis fordobles med intervaller på en til tre dage op til den ønskede vedligeholdelsesdosis på 5 mg to gange daglig. 
The daily dose is subsequently increased by doubling the dose at intervals of one to three days up to the target maintenance dose of 5 mg twice daily.
Cerebral iskæmi inklusiv iskæmisk stroke og forbigående iskæmiske anfald, svækkelse af psykomotoriske evner, brændende følelse, parosmi 
Cerebral ischaemia including ischaemic stroke and transient ischaemic attack, psychomotor skills impaired, burning sensation, parosmia
Blodprøveresultater der viser mere kalium i blodet end normalt 
• Blood tests showing more potassium than usual in your blood.
Fotosensibilitetsreaktioner 
Photosensitivit y reaction
Slovenien 
Slovenia
Anafylaktiske eller anafylaktoide reaktioner, øget niveau af antinukleare antistoffer 
Anaphylactic or anaphylactoid reactions, antinuclear antibody increased
Dosis kan fordobles efter intervaller på to til fire uger for progressivt at nå blodtryksmålet; den maksimalt 
The dose can be doubled at interval of two to four weeks to progressively achieve target blood pressure; the maximum permitted dose of TRITACE is 10 mg daily.
Norge: 
Norway:
ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN Opbevares utilgængeligt for børn. 
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Irland: 
Ireland:
Lægemiddelform Administrations-vej 
Route of administration
CHMP vedtog, at den anbefalede startdosis til patienter med diabetes og mikroalbuminuri er 1,25 mg Tritace én gang dagligt. 
The CHMP agreed that in patients with diabetes and microalbuminuria the recommended initial dose is 1.25 mg of Tritace once daily.
INSTRUKTIONER VEDRØRENDE ANVENDELSEN [Udfyldes nationalt] 
INSTRUCTIONS ON USE [To be completed nationally]
til koncentrere 
• Difficulty concentrating
I alle lande, hvor indikationen kongestiv hjerteinsufficiens er godkendt, er den anbefalede startdosis 0,25 mg dagligt, og den maksimalt 
In all countries where the congestive heart failure indication has been approved the initial recommended dose is 0.25 mg daily and the maximum permitted dose is 10 mg daily.
Oral anvendelse 
Oral use.
Medicin mod sukkersyge såsom tabletter der nedsætter blodsukkeret eller insulin. 
• Medicines for diabetes such as oral glucose lowering medicines and insulin.
Ved påvist graviditet bør behandling med ACE-hæmmere seponeres omgående, og alternativ antihypertensiv behandling eventuelt indledes. 
When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
Tjekkiet 
Czech Republic
Hyperkaliæmi er blevet observeret hos en antal patienter i behandling med ACE-hæmmere inklusive TRITACE. Patienter med risiko for udvikling af hyperkaliæmi inkluderer patienter med nyreinsufficiens, alderdom (> 70 år), ukontrolleret diabetes mellitus, eller dem i behandling med kaliumsalte, kaliumbesparende diuretika og andre aktive stoffer, der øger plasmakalium, eller tilstande såsom dehydrering, akut dekompenserende hjerte eller metabolisk acidose. 
Patients at risk for development of hyperkalaemia include those with renal insufficiency, age (> 70 years), uncontrolled diabetes mellitus, or those using potassium salts, potassium retaining diuretics and other plasma potassium increasing active substances, or conditions such as dehydration, acute cardiac decompensation, metabolic acidosis.
tilbage holder mere vand end vanligt. 
• Passing more water (urine) than usual over the day
WINTHROP MEDICAMENTS 1-13 Boulevard Romain Rolland F-75159 Paris, Cedex 14 Frankrig 
WINTHROP MEDICAMENTS 1-13 Boulevard Romain Rolland F-75159 Paris, Cedex 14 France
BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER, ETIKETTERINGEN OG INDLÆGSSEDLEN 
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Skal i behandling for bi eller hvepsestik for at nedsætte en allergisk reaktion (desensibilisering) 
• If you are going to have treatment to reduce your allergy to bee or wasp stings (desensitization)
til det eksisterende medicinske regime versus placebo hos 3.577 patienter, der var mindst 55 år gamle (ingen øvre aldersgrænse), med overvægt af type 2 diabetes (og mindst én yderligere CV risikofaktor), normotensiv eller hypertensive. 
The MICRO-HOPE study, a predefined substudy from HOPE, investigated the effect of the addition of ramipril 10 mg to the current medical regimen versus placebo in 3,577 patients at least ≥ 55 years old (with no upper limit of age), with a majority of type 2 diabetes (and at least another CV risk factor), normotensive or hypertensive.
Kløe og unormale hud tilstande såsom følelsesløshed, prikkende eller brændende fornemmelse i huden (parastesi) 
• Itching and unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia)
Ramipril sanofi-aventis 
Triatec Ramipril sanofi-aventis
Mave-tarmkanalen Gastrointestinal inflammation, fordøjelsesforstyrrelser, ubehag i maven, dyspepsi, diarre, kvalme, opkastning. 
Gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, diarrhoea, nausea, vomiting
Frankrig: 
France:
Den almindelige dosis er 5 mg eller 10 mg én gang dagligt 
• The usual dose is 5 mg or 10 mg once daily.
FARMAKOLOGISKE EGENSKABER 
PHARMACOLOGICAL PROPERTIES
Behandling af hjertesvigt 
Treatment of heart failure
Grækenland 
Greece
Tablet Kapsel, hård 
Tablet Hard Capsule
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) [Udfyldes nationalt] 
MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Den aktuelle indikation for ramipril ved hypertension er 
The current indication of ramipril in hypertension differs among the EU countries.
Hovedpine, svimmelhed 
Headache, dizziness
SANOFI-AVENTIS SLOVAKIA s.r.o. 
Slovak Republic SANOFI-AVENTIS SLOVAKIA s.r.o.
Et randomiseret, dobbeltblindet parallelgruppe-, placebokontrolleret multicenterstudie, REIN-studiet, havde som mål at vurdere effekten af behandling med ramipril på graden af forværring i glomerulærfunktionsraten (GFR) hos 352 normotensive eller hypertensive patienter (18-70 år), der led af mild til svær proteinuri (mild: 
The REIN study, a multicenter randomized, double-blind parallel group, placebo-controlled study aimed at assessing the effect of treatment with ramipril on the rate of decline of glomerular function rate (GFR) in 352 normotensive or hypertensive patients (18-70 years old) suffering from mild (i.e. mean urinary protein excretion > 1 and < 3 g/24 h) or severe proteinuria (≥ 3 g/24 h) due to chronic non-diabetic nephropathy.
to ugers behandling og - efter yderligere to til tre uger - at forøge den op til den ønskede vedligeholdelsesdosis på 10 mg TRITACE en gang daglig. 
It is recommended to double the dose after one or two weeks of treatment and - after another two to three weeks - to increase it up to the target maintenance dose of 10 mg TRITACE once daily.
SÆRLIGE OPBEVARINGSBETINGELSER [Udfyldes nationalt] 
SPECIAL STORAGE CONDITIONS [To be completed nationally]
- ”Overfølsomhed over for ramipril, et eller flere af hjælpestofferne eller enhver anden ACE-hæmmer (se afsnit 6.1) - Tidligere hereditært eller idiopatisk angioødem - Ekstrakorporale behandlinger, som medfører kontakt af blod med negativt ladede overflader (se afsnit 4.5) - Signifikant bilateral nyrearteriestenose eller nyrearteriestenose i en enkelt fungerende nyre - Graviditet i 2. 
- Hypersensitivity to the active substance, to any of the excipients or any other ACE (Angiotensin Converting Enzyme) inhibitors (see section 6.1) - History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or AIIRAs) - Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5) - Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney - 2nd and 3rd trimester of pregnancy (see sections 4.4 and 4.6) - Ramipril must not be used in patients with hypotensive or haemodynamically unstable states.
Tjekkiet: 
Czech Republic:
til 4 uger forekommer relevant baseret på individuel variabilitet. CHMP vedtog følgende: "Dosis fastlægges efter individuel vurdering ud fra patientprofilen (se afsnit 4.4) og blodtrykskontrol. 
The CHMP agreed the following: “The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Du kan anvende TRITACE: 
TRITACE can be used:
”Behandling af symptomatisk hjerteinsufficiens”. 
- Treatment of symptomatic heart failure.
Almindelig 
Common
Intestinalt angioødem er blevet rapporteret hos patienter i behandling med ACE-hæmmere inklusive TRITACE (se pkt. 
Intestinal angioedema has been reported in patients treated with ACE inhibitors including TRITACE (see section 4.8).
Belgien: 
Belgium:
Endelig er den anbefalede startdosis til patienter med ikke-diabetisk nefropati med makroproteinuri ≥3g/dag 1,25 mg Tritace én gang dagligt. 
And finally, for patients with non diabetic nephropathy macroproteinuria ≥3gm/day, the recommended initial dose is 1.25 mg of Tritace once daily.
Røde, kløende, hævede, fugtige øjne 
• Red, itchy, swollen or watery eyes
inden for 24 timer efter myokardieinfarkt med den laveste dosis på 1,25 mg dagligt (som anvendes som første dosis ved hjerteinsufficiens-indikationen), forudsat at patienten er hæmodynamisk stabil og det kontrolmæssige fortilfælde med ordlyden for lisinopril. 
The MAH calls on a high level of evidence for ACE-Is administered in the first 24 hours following acute myocardial infarction (MI) in international recommendations, to justify initiating therapy with 24 hours of MI at the lowest dose of 1.25 mg daily (that used as first dose in the heart failure indication), provided that stable haemodynamic conditions are met and the regulatory precedent with lisinopril wording.
AVENTIS PHARMA LTD 50 Kings Hill Avenue Kings Hill 
United Kingdom AVENTIS PHARMA LTD 50 Kings Hill Avenue
BILAG III PRODUKTRESUME, ETIKETTERING OG INDLÆGSSEDDEL 
ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Hvis startdosis på 2,5 mg ikke tolereres, bør der gives 1,25 mg to gange daglig i to dage, før dosis øges til 2,5 mg og 5 mg to gange daglig. 
If the initial 2.5 mg dose is not tolerated a dose of 1.25 mg twice a day should be given for two days before increasing to 2.5 mg and 5 mg twice a day.
Sverige: 
Sweden:
Østrig: 
Austria:
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt] {Navn} 
Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally] {Name and address} {tel} {fax} {e-mail}
Procainamid (mod problemer med hjerterytmen) 
• Procainamide (for heart rhythm problems).
Tyskland: 
Germany:
- Der er rapporteret hoste ved brug af ACE-hæmmere. 
Cough has been reported with the use of ACE inhibitors.
65926 Frankfurt am Main Tyskland 
65926 Frankfurt am Main Germany
Hvis dosis ikke kan øges til 2,5 mg to gange daglig bør behandlingen seponeres. 
If the dose cannot be increased to 2.5 mg twice a day the treatment should be withdrawn.
Lettere tendens til blå mærker, længere blødningsperioder, tegn på blødninger (f.eks. blødning fra tandkødet), lilla mærker på huden, lettere tendens til at få infektioner, halsbetændelse, feber, træthedsfornemmelse, svimmel eller bleghed. 
• Bruising more easily, bleeding for longer than normal, any sign of bleeding (e.g. bleeding from the gums), purple spots blotching on the skin or getting infections more easily than usual, sore throat and fever, feeling tired, faint, dizzy or having pale skin.
tage dit blodtryk. 
Your doctor will need to check your blood pressure.
Øget blodnatrium 
Blood potassium increased
Akut leverunsufficiens eller cytolitisk hepatitis (i meget få tilfælde med dødelig udgang) 
Acute hepatic failure, cholestatic or cytolytic hepatitis (fatal outcome has been very exceptional).
UDLØBSDATO 
EXPIRY DATE
Cypern: Triatec 2.5 mg δισκία, Triatec 5 mg δισκία, Triatec 10 mg δισκία 
Cyprus: Triatec 2.5 mg δισκία, Triatec 5 mg δισκία, Triatec 10 mg δισκία
Nederlandene: 
Netherlands:
og mortalitet hos patienter med: i) manifest aterotrombotisk kardiovaskulær sygdom (tidligere koronar hjertesygdom eller slagtilfælde eller perifer vaskulær sygdom), eller ii) diabetes med mindst én kardiovaskulær risikofaktor”. 
The CHMP adopted the following: “Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with: i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or ii) diabetes with at least one cardiovascular risk factor”.
Immunsystemet 
Immune system disorders
Produktresuméet, etiketteringen og indlægssedlen fremgår af bilag III for Tritace og tilknyttede navne (se bilag I). 
the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Tritace and associated names (see Annex I).
Blodprøveresultater der viser lavere indhold af natrium end normalt 
• Blood tests showing less sodium than usual in your blood
Hudpletter og kolde hænder og fødder 
• Blotches on your skin and cold extremities
Absorptionen er, baseret på urinopsamling, mindst 56 % og er 
Based on urinary recovery, the extent of absorption is at least 56 % and is not significantly influenced by the presence of food in the gastrointestinal tract.
Hyperkaliæmi 
Hyperkalaemia
Nedsættelse af mortalitet af den akutte fase af myokardieinfarkt hos patienter med kliniske tegn på hjerteinsufficiens, når behandlingen påbegyndes > 48 timer efter akut myokardieinfarkt”. 
- Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours following acute myocardial infarction.
ikke kan pumpe tilstrækkeligt blod rundt i din krop (hjertesvigt) Til forebyggelse efter blodprop 
• To treat your heart when it cannot pump enough blood to the rest of your body (heart failure)
One Onslow Street Guildford Surrey GU1 4YS UK 
Guildford Surrey GU1 4YS UK
Psykiske forstyrrelser 
Psychiatric disorders
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER [Udfyldes nationalt] 
STATEMENT OF ACTIVE SUBSTANCE(S) [To be completed nationally]
sig og reagere, og udgør derfor en risiko i situationer hvor disse evner er særligt vigtige (f.eks.ved betjening af motorkøretøj eller maskiner). 
Some adverse effects (e.g. symptoms of a reduction in blood pressure such as dizziness) may impair the patient's ability to concentrate and react and, therefore, constitute a risk in situations where these abilities are of particular importance (e.g. operating a vehicle or machinery).
slagtilfælde eller perifer vaskulær sygdom i anamnesen), eller diabetes mellitus med mindst én ekstra risikofaktor (dokumenteret mikroalbuminuri, hypertension, forhøjet totalkolesterolniveau, lavt HDL kolesterolniveau eller rygning). 
Patients with increased risk of cardiovascular disease following either atherothrombotic cardiovascular disease (history of coronary heart disease, stroke or peripheral vascular disease) or diabetes mellitus with at least one additional risk factor (documented microalbuminuria, hypertension, elevated total cholesterol level, low high-density lipoprotein cholesterol level or cigarette smoking) were included in the study.
Italien: 
Italy:
Ramiprilat, den aktive metabolit fra prodrug ramipril, hæmmer enzymet dipeptidylcarboxypeptidase I (som er 
Ramiprilat, the active metabolite of the prodrug ramipril, inhibits the enzyme dipeptidylcarboxypeptidase I (synonyms: angiotensin-converting enzyme; kininase II).
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Det er kendt, at eksponering for ACE-hæmmere/Angiotensin II Receptor Antagonister i graviditetens andet og tredje trimester forårsager human føtotoksicitet (nedsat nyrefunktion, oligohydramnion, forsinket ossifikation af kraniet) og neonatal toksicitet (nyreinsufficiens, hypotension, hyperkaliæmi) (se også pkt. 5.3). 
ACE inhibitor/ Angiotensin II Receptor Antagonist (AIIRA) therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
[Se bilag I - Udfyldes nationalt] 
[See Annex I - To be completed nationally]
Blodprøveresultater der viser ændring i lever, bugspytkirtel og nyrernes funktion 
• Blood tests showing changes in the way your liver, pancreas or kidneys are working.
Angioødem er blevet rapporteret hos patienter i behandling med ACE-hæmmere inklusive ramipril (se pkt. 
Angioedema has been reported in patients treated with ACE inhibitors including ramipril (see section 4.8).
Har dårligt hjerte, lever eller nyrer 
• If you have heart, liver or kidney problems
Angioødem 
Angioedema
til at genskabe hæmodynamisk stabilitet, såsom administration af alpha 1 adrenerge agonister eller angiotensin II (angiotensinamid). 
Suggested measures include primary detoxification (gastric lavage, administration of adsorbents) and measures to restore haemodynamic stability, including, administration of alpha 1 adrenergic agonists or angiotensin II (angiotensinamide) administration.
Nervesystemet 
Nervous system disorders
Aftuøs stomatit mund. 
• Swollen mouth
− Behandling af nyrelidelser: o Begyndende glomerulær diabetisk nefropati defineret ved tilstedeværelsen af mikroalbuminuri o Manifest glomerulær diabetisk nefropati defineret ved makroproteinuri hos patienter med mindst én kardiovaskulær risikofaktor (se pkt. 
- Treatment of renal disease: o Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria, o Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1), o Manifest glomerular non diabetic nephropathy as defined by macroproteinuria ≥ 3 g/day (see section 5.1).
Storbritannien/UK 
United Kingdom