FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of acute overdose, the likely symptomatology may be peripheral vasodilation with a fall in blood pressure and reflex tachycardia.
Danish: De mest sandsynlige symptomer ved akut overdosering er perifer vasodilatation med blodtryksfald og reflekstakykardi.
English: Corneal ulcer, conjunctival ulcer, conjunctivitis (see section
Danish: Ulcus corneae, ulcus conjunctivae, conjunctivitis (se pkt.4.4)
English: <Invented name> is indicated in adults for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or have a contraindication or intolerance to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists).
Danish: Angicor er indiceret til symptomatisk behandling af stabil angina pectoris hos voksne, der ikke er tilstrækkeligt kontrolleret med, har en kontraindikation mod eller ikke tåler førstevalgsbehandling af angina pectoris (såsom betablokkere og/eller calciumantagonister).
English: Therefore, caution is advised when concomitant use of corticosteroids is considered.
Danish: Der rådes derfor til forsigtighed, hvis samtidig behandling med kortikosteroider overvejes.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister strip/ 10 mg and 20 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterkort / 10 mg og 20 mg
English: These results suggest that testicular toxicity by nicorandil is related to a sustained decrease in blood flow caused by reduction of cardiac output.
Danish: Disse resultater tyder på, at testikeltoksicitet forårsaget af nicorandil er relateret til vedvarende nedsat blodgennemstrømning forårsaget af nedsat minut volumen.
English: The usual starting dose is 10 mg twice daily (bid), in the morning and in the evening preferably.
Danish: Den sædvanlige startdosis er 10 mg to gange dagligt, fortrinsvis morgen og aften.
English: • Medicines that widen the blood vessels.
Danish: • Medicin, der udvider blodkarrene.
English: It is recommended that the dose be titrated upwards in accordance with the patient's needs, response and tolerance up to 40 mg twice daily, if necessary.
Danish: Det anbefales, at dosis om nødvendigt titreres op til 40 mg to gange dagligt afhængigt af patientens behov, respons og tolerance.
English: The metabolism of nicorandil appears not to be significantly modified by cimetidine or rifampicine, respectively an inhibitor and an inducer of liver microsomal mixed-function oxidases.
Danish: Nicorandils metabolisme synes ikke at ændres i signifikant grad af hverken cimetidin eller rifampicin, som henholdsvis er en hæmmer og en induktor af mikrosomale leveroxidaser med blandet funktion.
English: This effect can be increased in conjunction with alcohol or other medicinal products with blood pressure lowering effect (e.g. vasodilators, tricyclic antidepressants) (see section 4.5).
Danish: Denne effekt kan øges i forbindelse med alkohol eller andre lægemidler med blodtrykssænkende effekt (f.eks. vasodilatorer, tricykliske antidepressiva) (se pkt.
English: Liver disorders such as hepatitis, cholestasis, or jaundice
Danish: Leversygdom me som hepatitis, kolestase eller gulsot
English: These metabolites represented the major route of transformation of nicorandil.
Danish: Disse metabolitter udgør størstedelen af nironadils omdannelse.
English: Tell your doctor, if you are taking any of the following:
Danish: Fortæl det til lægen, hvis du tager en eller flere af følgende typer medicin:
English: • a slow elimination phase occurring approximately 12 hours following 20 mg oral dose bid.
Danish: En langsom eliminationsfase, der indtræder ca. 12 timer efter en dosis på 20 mg to gange dagligt.
English: Nicorandil, a nicotinamide ester, is a vasodilator agent with a dual mechanism of action, which leads to relaxation of smooth tonic vascular muscles in both venous and arterial part of vessels.
Danish: Nicorandil, som er en nicotinamidester, er en vasodilator med dobbelt virkningsmekanisme, som resulterer i afslapning af den vaskulære glatte muskulatur i både det venøse og det arterielle karsystem.
English: Additional investigative studies for testicular toxicity revealed decreased blood flow in the testis and decreased blood levels of testosterone.
Danish: testikeltoksicitet viste nedsat blodgennemstrømning i testis og nedsat koncentration af testosteron i blodet.
English: It improves the blood and oxygen supply of your heart muscle and reduces its workload.
Danish: Dermed forbedres blodtilførslen og iltforsyningen til hjertet, og belastningen på hjertet mindskes.
English: Do not take out or separate tablet from the blister strip until intake.
Danish: Du må ikke tage tabletten ud af blisterpakningen, før du skal sluge den.
English: Nicorandil and its metabolites are mainly excreted by urinary route, faecal excretion being very low.
Danish: Nicorandil og dets metabolitter udskilles hovedsageligt i urinen, idet udskillelsen i fæces er meget langsom.
English: <Invented name> has an influence on the ability to drive and use machines.
Danish: Angicor påvirker evnen til at føre motorkøretøj og betjene maskiner.
English: Caution is advised when concomitant use is considered.
Danish: Der skal udvises forsigtighed, hvis samtidig behandling overvejes.
English: Concurrent use of nicorandil and phosphodiesterase 5 inhibitors, e.g. sildenafil, tadalafil, vardenafil, is contraindicated, since it can lead to a serious drop in blood pressure (synergic effect).
Danish: Samtidig anvendelse af nicorandil og fosfodiesterase-5-hæmmere som f.eks. sildenafil, tadalafil og vardenafil er kontraindiceret, da det kan medføre alvorligt blodtryksfald (synergistisk effekt).
English: • If you have a low blood pressure.
Danish: • Hvis du har lavt blodtryk.
English: It is used in adult patients who do not tolerate or cannot take heart medicines called beta-blockers and/or calcium antagonists.
Danish: Det anvendes til voksne patienter, som ikke tåler eller ikke kan tage hjertemedicin som betablokkere og/eller calciumantagonister.
English: Patients taking acetylsalicylic acid or NSAIDs (Non Steroid Anti Inflammatory Drugs) concomitantly are at increased risk for severe complications such as gastrointestinal haemorrhage.
Danish: Patienter, der samtidig tager acetylsalicylsyre eller NSAID (nonsteroide antiinflammatoriske midler) har en øget risiko for alvorlige komplikationer som f.eks. gastrointestinal blødning.
English: Talk straight away to your doctor if you experience any of the following: Nicorandil may cause injuries to your gastrointestinal tract such as ulcers in the mouth, tongue, stomach, guts (small and large), back passage.
Danish: Tal staks med lægen, hvis du får en eller flere af følgende bivirkninger: Nicorandil kan forårsage skader på mave-tarm-kanalen, som f.eks. sår i munden, på tungen, i maven, tarmene (tyktarmen og tyndtarmen) eller endetarmen.
English: - Your doctor may increase the dose up to 20 mg twice daily depending on your needs, response to treatment and tolerance.
Danish: - Din læge vil muligvis øge din dosis til højst 20 mg to gange dagligt afhængigt af dit behov,
English: • if you have heart problems such as cardiogenic shock, or left ventricular failure with low filling pressure or cardiac decompensation or shock.
Danish: • hvis du har problemer med hjertet, f.eks. kardiogent shock, venstresidigt hjertesvigt med lavt fyldningstryk, hjertesvigt eller shock.
English: • Medicines to treat pulmonary hypertension such as riociguat.
Danish: • Medicin til behandling af forhøjet blodtryk i lungerne som f.eks. riociguat.
English: This can develop problems such as bleeding (blood in your stools or vomit), fistula (abnormal tube-like passage from one body cavity to another or to the skin), wholes, abscess, weight loss.
Danish: Dette kan give problemer som f.eks. blødning (blod i afføringen, opkast), fistler (unormal rør-lignende passage fra et hulrum i kroppen til et andet eller til huden), perforation (huller), bylder og vægttab.
English: Absorption After oral administration, nicorandil is absorbed rapidly and completely from the gastrointestinal tract, independent from food intake.
Danish: Nicorandil absorberes hurtigt og fuldstændigt fra mave-tarm-kanalen efter oral administration og uafhængigt af fødeindtagelse.
English: • Nicorandil may cause injuries to your gastrointestinal tract such as ulcers.
Danish: • Nicorandil kan forårsage skader på mave-tarm-kanalen som f.eks. sår.
English: It is not known whether nicorandil passes in human milk.
Danish: Man ved ikke, om nicorandil udskilles i rmælken hos menneskeer.
English: In addition, the activation of the potassium channel leads to cardioprotective effects mimicking ischemic pre-conditioning.
Danish: Derudover medfører aktivering af kaliumkanaler kardiobeskyttende virkning, der minder om iskæmisk prækonditionering.
English: Summary of product characteristics, labelling and package leaflet
Danish: Bilag III Produktresume, etikettering og indlægsseddel
English: Concomitant use of soluble guanylate cyclase stimulator (such as riociguat) is contraindicated, since it can lead to a serious drop in blood pressure.
Danish: Samtidig anvendelse af opløselige guanylatcyklasestimulatorer (som f.eks. riociguat) er kontraindiceret, da det kan medføre alvorligt blodtryksfald.
English: What you need to know before you take <Invented name>
Danish: Det skal du vide, før du begynder at tage Angicor
English: If you take more <Invented name> than you should If you take more tablets than you should, or if a child has swallowed any of your tablets, tell a doctor or go to a hospital casualty department straight away.
Danish: Hvis du har taget for mange tabletter, eller hvis et barn har slugt en eller flere af dine tabletter, skal du straks søge lægehjælp eller tage til nærmeste skadestue.
English: • Hypersensitivity to nicorandil or to any of the excipients listed in section 6.1
Danish: • Overfølsomhed over for nicorandil eller over for et eller flere af hjælpestofferne anført i pkt.
English: Also some medicines may affect the way <Invented name> works.
Danish: Nogle typer medicin kan også påvirke virkningen af Angicor.
English: Children • <Invented name> is not recommended in children.
Danish: Børn Angicor må ikke anvendes til børn.
English: Talk to your doctor or pharmacist before taking <Invented name>:
Danish: Tal med lægen eller apotekspersonalet, inden du begynder at tage Angicor:
English: Ulcers can occur at other site such as: skin, genital tract and nasal passages or around a stoma (in those with an artificial opening for waste removal such as a colostomy or ileostomy).
Danish: Der kan også opstå sår andre steder: på huden, i urinvejene og i næsen eller ved en stomi (kunstig åbning til afføring som f.eks. kolostomi eller ileostomi).
English: • Medicines to treat high blood pressure.
Danish: • Medicin mod forhøjet blodtryk.
English: The tablets are sensitive to moisture; hence the patients should be advised to keep the tablets in their blister until intake.
Danish: Patienterne skal derfor informeres om at opbevare tabletterne i blisterpakningen indtil anvendelse.
English: In patients concomitantly receiving NSAIDs including acetylsalicylic acid for both cardiovascular prevention and anti-inflammatory doses, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and haemorrhage (see section 4.4).
Danish: Hos patienter, der samtidigt tager NSAID, herunder acetylsalicylsyre både til forebyggelse af kardiovaskulær sygdom og i antiinflammatoriske doser, er der en øget risiko for alvorlige komplikationer som f.eks. gastrointestinal ulceration, perforation og blødning (se pkt.
English: This results in an increased pooling in capacitance vessels with a decrease in preload.
Danish: Dette resulterer i dilation af kapaticanskarrene og nedsat preload.
English: Complications of gastrointestinal ulceration such as perforation, fistula, or abscess formation sometimes leading to gastrointestinal haemorrhage and weight loss have been reported (see section
Danish: Der er rapporteret komplikationer til gastrointestinal ulceration som f.eks. perforation, fistler eller abscesdannelse, som til tider har medført gastrointestinal blødning og vægttab (se pkt.
English: If ulceration(s) develops, nicorandil should be permanently discontinued (see section 4.8).
Danish: Hvis der opstår ulceration(er), skal nicorandil seponeres permanent (se pkt.
English: As a precautionary measure, it is preferable to avoid the use of <Invented name> during pregnancy.
Danish: For en sikkerheds skyld bør Angicor undgås under graviditet.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Contains a drying agent in each blister strip.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Hvert blisterkort indeholder et tørremiddel.
English: Very rare conjunctivitis, conjunctival ulcer and corneal ulcer have been reported with nicorandil.
Danish: Conjunctivitis, ulcus conjunctivae og ulcus corneae er blevet rapporteret meget sjældent med nicorandil.
English: • Red, itchy, swollen or watery eyes (conjunctivitis)
Danish: • Røde, kløende, hævede eller rindende øjne (konjunktivitis)
English: Nicorandil should be used with care in combination with other medical products that may increase potassium levels, especially in patients with moderate to severe renal impairment (see sections 4.5 and 4.8).
Danish: Der skal udvises forsigtighed, når nicorandil anvendes sammen med andre lægemidler, der kan forhøje kaliumniveauet, især hos patienter med moderat til svært nedsat nyrefunktion (se pkt.
English: Contents of the pack and other information [To be completed nationally]
Danish: Pakningsstørrelser og yderligere oplysninger [Udfyldes nationalt]
English: Rash, pruritus Angioedema, Skin and mucosal ulcerations (mainly peri-anal ulcerations, genital ulcerations and parastomal ulcerations) (see section
Danish: Udslæt, pruritus Angioødem, Hud- og slimhindeulcerationer (hovedsageligt perianale, genitale og parastomale ulcerationer) (se pkt.4.4)
English: This leaflet was last revised in. [To be completed nationally]
Danish: Denne indlægsseddel blev senest revideret [Udfyldes nationalt]
English: or if you are suffering from renal impairment or taking other medical products that may increase potassium levels.
Danish: hvis du har nedsat nyrefunktion, eller hvis du tager anden medicin, der kan øge indholdet af kalium i kroppen.
English: It possesses a potassium-channel opening effect.
Danish: Det virker ved at åbne kaliumkanaler.
English: Gastrointestinal ulcerations, skin and mucosal ulcerations have been reported with nicorandil (see section 4.8).
Danish: Gastrointestinale ulcerationer og ulcerationer i hud og slimhinder er blevet rapporteret med nicorandil (se pkt.
English: • Use of soluble guanylate cyclase stimulator(s) (such as riociguat) since it can lead to a serious fall in blood pressure (see section 4.5)
Danish: • Brug af opløselige guanylatcyklasestimulatorer (som f.eks. riociguat), da det kan medføre alvorligt blodtryksfald (se pkt.
English: The volume of distribution of nicorandil after intravenous (iv) dosing is 1.04 L/kg of body weight.
Danish: administration er 1,04 l/kg kropsvægt.
English: It is included in the pack to protect <Invented name> tablets from moisture.
Danish: Det er en del af pakningen og skal beskytte Angicor mod fugt.
English: You may have eye injuries, stop taking <Invented name> and contact your doctor immediately.
Danish: Stop med at tage Angicor og kontakt straks lægen.
English: Gastrointestinal perforations in context of concomitant use of nicorandil and corticosteroids have been reported.
Danish: Der er rapporteret om gastrointestinale perforationer i forbindelse med samtidig behandling med nicorandil og kortikosteroider.
English: Caution is advised when nicorandil is used in combination with other medical products that may increase potassium levels (see sections 4.4 and 4.8).
Danish: Der skal udvises forsigtighed, hvis nicorandil anvendes sammen med andre lægemidler, der kan øge kaliumniveauet (se pkt.
English: Cutaneous vasodilatio n with flushing
Danish: Kutan vasodilation med rødme
English: • Use of phosphodiesterase 5 inhibitors, since this can lead to a serious drop in blood pressure
Danish: • Brug af fosfodiesterase-5-hæmmere, da det kan medføre alvorligt blodtryksfald (se pkt.
English: Gastrointestinal perforation in the context of concomitant use of nicorandil and corticosteroids has been reported.
Danish: Der er rapporteret om gastrointestinal perforation i forbindelse med samtidig behandling med nicorandil og kortikosteroider.
English: If ulceration(s) develops, nicorandil should be discontinued (see section 4.8).
Danish: Hvis der opstår ulceration(er), skal nicorandil seponeres (se pkt.
English: G6PD deficiency <Invented name> should be used with caution in patients with glucose-6-phosphate-dehydrogenase deficiency.
Danish: Angicor skal anvendes med forsigtighed til patienter med glucose-6-phosphat-dehydrogenasemangel.
English: Do not take <Invented name>: • if you are allergic to nicorandil or any of the other ingredients of this medicine (listed in section
Danish: • hvis du er allergisk over for nicorandil eller et af de øvrige indholdsstoffer i Angicor (angivet i punkt 6).
English: You may feel blood pressure lowering effect such as dizziness, feeling of weakness.
Danish: Tag emballagen med. Du kan få symptomer på nedsat blodtryk som f.eks. svimmelhed eller svaghedsfølelse.
English: Gastrointestina l ulcerations (stomatitis, aphtosis, mouth ulcer, tongue ulcer, small intestinal ulcer, large intestinal ulcer, anal ulcer) (see below and section 4.4)
Danish: Gastrointestinale ulcerationer (stomatitis, aftose, sår i munden, sår på tungen, sår på tyndtarmen, sår på tyktarmen, analt ulcus) (se nedenfor og pkt.
English: Gastrointestinal haemorrhage secondary to gastrointestinal ulceration has been reported with nicorandil.
Danish: Der er rapporteret om gastrointestinal blødning sekundært til gastrointestinal ulceration i forbindelse med behandling med nicorandil.
English: • Medicines that increase blood potassium levels.
Danish: • Medicin, der øger indholdet af kalium i blodet.
English: - Eye ulcerations
Danish: - Ulcerationer i øjet
English: Decrease in blood pressure (see section
Danish: Blodtryksfald (se pkt.4.4)
English: • Acute pulmonary oedema
Danish: • Akut lungeødem
English: This can develop problems such as bleeding, fistula, wholes, abscess, especially if you have diverticular disease
Danish: Dette kan medføre problemer som f.eks. blødning, fistler (unormal rør-lignende passage fra et hulrum i kroppen til et andet eller til huden), perforationer (huller) og bylder, især hvis du har en divertikelsygdom (en sygdom i fordøjelsessystemet, som påvirker tyktarmen).
English: Gastrointestina l haemorrhage (see section
Danish: Gastrointestinal blødning (se pkt.
English: DATE OF FIRST AUTHORISATION: RENEWAL OF THE AUTHORISATION [To be completed nationally]
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Caution is advised if nicorandil is used in combination with other medicinal products with blood pressure lowering effect (see section 4.5 and 4.8).
Danish: Nicorandil skal anvendes med forsigtighed sammen med andre lægemidler med blodtrykssænkende effekt (se pkt.
English: Method of administration <Invented name> is administered by oral route.
Danish: Angicor administreres oralt.
English: PHARMACEUTICAL PARTICULARS [To be completed nationally]
Danish: FARMACEUTISKE OPLYSNINGER [Udfyldes nationalt]
English: Other medicines and <Invented name>
Danish: Brug af anden medicin sammen med Angicor
English: Dizziness
Danish: • Hudrødme
English: What <Invented name> is and what it is used for What you need to know before you take <Invented name> How to take <Invented name> Possible side effects
Danish: Det skal du vide, før du begynder at tage Angicor Sådan skal du tage Angicor Bivirkninger
English: Other side effects include: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer)
English: Ikorel and associated names (see Annex I) 10 mg tablets Dancor and associated names (see Annex I) 10 mg tablets Ikorel and associated names (see Annex I) 20 mg tablets] Dancor and associated names (see Annex I) 20 mg tablets [See Annex I - To be completed nationally] nicorandil
Danish: Angicor og relaterede navne (Se bilag I) 10 mg tabletter Angicor og relaterede navne (Se bilag I) 20 mg tabletter [Se bilag I - Udfyldes nationalt] nicorandil
English: OTHER Do not swallow drying agent.
Danish: ANDET Tørremidlet må ikke sluges.
English: Headach e
Danish: Svaghedsfølels e
English: Ikorel and associated names (see Annex I) 10 mg tablets Dancor and associated names (see Annex I) 10 mg tablets Ikorel and associated names (see Annex I) 20 mg tablets] Dancor and associated names (see Annex I) 20 mg tablets [See Annex I - To be completed nationally]
Danish: Angicor og relaterede navne (Se bilag I) 10 mg tabletter Angicor og relaterede navne (Se bilag I) 20 mg tabletter [Se bilag I - Udfyldes nationalt]
English: • if you are taking medicines to treat erectile dysfunction such as sildenafil, tadalfil, vardenafil (phosphodiesterase inhibitors) or medicines to treat pulmonary hypertension such as riociguat (guanylate cyclase stimulators).
Danish: (fosfodiesterase-hæmmere) eller medicin til behandling af forhøjet blodtryk i lungerne som f.eks. riociguat (guanylatcyklase-stimulatorer).
English: • Cornea injuries
Danish: • Skader på hornhinden
English: How to take <Invented name>
Danish: Sådan skal du tage Angicor
English: Desiccant
Danish: Mundsår
English: In addition, serious adverse reactions including ulcerations and their complications (see section 4.4) were reported during the post marketing surveillance of nicorandil.
Danish: 4.4) rapporteret i post-marketingovervågning af nicorandil.
English: Take the medicine pack with you.
Danish: - Gem indlægssedlen.
English: Rectal bleeding
Danish: Mave-tarm-kanalen Rektal blødning
English: Driving and using machines <Invented name> may cause dizziness or weakness.
Danish: Angicor kan forårsage svimmelhed eller svaghedsfølelse.
English: • Stomach aches.
Danish: • Mavesmerter.
English: Ikorel and associated names (see Annex I) 10 mg tablets Dancor and associated names (see Annex I) 10 mg tablets Ikorel and associated names (see Annex I) 20 mg tablets] Dancor and associated names (see Annex I) 20 mg tablets
Danish: INFORMATION I BRAILLE-SKRIFT Angicor og relaterede navne (Se bilag I) 10 mg Angicor og relaterede navne (Se bilag I) 20 mg
English: EU/2/04/044/014 Aivolsin 625 mg/g Granules for use in drinking water
Danish: EU/2/04/044/013 Aivlosin 42,5 mg/g Oralt pulver
English: Packaging Content Package size
Danish: Indgivelsesvej Emballage
English: This summary was last updated in 03-2016.
Danish: Dette sammendrag blev sidst ajourført i 03-2016
English: Further care must be taken for up to six months.
Danish: Der skal udvises yderligere forsigtighed i op til seks måneder.
English: The dose is 0.15 mg per kilogram body weight.
Danish: Dosis er 0,15 mg pr. kg legemsvægt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Foscan on 24 October 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Foscan den 24. oktober 2001.
English: The full EPAR for Foscan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Foscan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Foscan
Danish: Andre oplysninger om Foscan
English: If a second treatment is necessary, this should take place at least four weeks later.
Danish: Hvis behandlingen må gentages, skal der gå mindst fire uger, før dette finder sted.
English: Each area of the tumour should be illuminated only once during each treatment.
Danish: Hvert område af svulsten bør kun belyses én gang under hver behandling.
English: This is a summary of the European public assessment report (EPAR) for Foscan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Foscan.