FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of hydroxocobalamin was generally associated with a normalisation of blood pressure (systolic blood pressure > 90 mmHg) in 17 of 21 patients (81%) who had low blood pressure (systolic blood pressure > 0 and ≤ 90 mmHg) after exposure to cyanide.
Danish: Administrationen af hydroxocobalamin var generelt forbundet med en normalisering af blodtrykket (systolisk blodtryk > 90 mmHg) hos 17 af 21 patienter (81 %), som havde lavt blodtryk (systolisk blodtryk > 0 og ≤ 90 mmHg) efter eksponering for cyanid.
English: The mean age of the paediatric patients was about six years and the mean dose of hydroxocobalamin was about 120 mg/kg body weight.
Danish: De pædiatriske patienters gennemsnitlige alder var omkring 6 år, og den gennemsnitlige dosis hydroxocobalamin var ca. 120 mg/kg legemsvægt.
English: Pustular rashes, which may last for several weeks, affecting mainly the face and the neck.
Danish: Pustuløst udslæt, som kan vare i flere uger og især viser sig på ansigt og hals.
English: The mean total amount of cobalamins-(III) excreted in urine during the collection period of 72 hours was approximately 60% of a 5 g dose and approximately 50% of a 10 g dose of Cyanokit.
Danish: Den gennemsnitlige totale mængde cobalamin-(III)-ioner, der blev udskilt i urinen i løbet af indsamlingsperioden på 72 timer, var ca. 60 % af en dosis på 5 g og ca. 50 % af en dosis på 10 g Cyanokit.
English: If overdose occurs, treatment is directed to the management of symptoms.
Danish: I tilfælde af overdosering skal behandlingen bestå af understøttende symptombehandling.
English: As physical and chemical incompatibilities were observed with a number of selected medicinal products that are frequently used in resuscitation efforts, these and other medicinal products must not be administered simultaneously in the same intravenous line as hydroxocobalamin.
Danish: Da der er påvist fysisk og kemisk uforligelighed med et antal udvalgte lægemidler, der ofte anvendes ved genoplivning, må disse og andre lægemidler derfor ikke administreres samtidig med hydroxocobalamin gennem den samme intravenøse adgang.
English: There is no widely available, rapid, confirmatory cyanide blood test.
Danish: Der findes ingen let tilgængelig og hurtig blodtest, der kan bekræfte en cyanidforgiftning.
English: Tell your doctor or other health care professional if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller andet sundhedspersonale, hvis du bruger anden medicin eller har gjort det for nylig.
English: In order to reflect the exposure to the sum of all derivatives, pharmacokinetics of cobalamins-(III) were investigated instead of hydroxocobalamin, requiring the concentration unit µg eq/mL (i.e. cobalamin-(III) entity without specific ligand).
Danish: For at kunne afspejle eksponeringen af alle derivaterne sammenlagt, blev farmakokinetikken for cobalamin-(III)-ioner undersøgt i stedet for hydroxocobalamins, hvilket nødvendiggjorde koncentrationsenheden µg eq/ml (dvs. cobalamin-(III)enheden uden specifik ligand).
English: Therefore, as a precaution, after Cyanokit administration, regular monitoring of renal function (including blood urea nitrogen and serum creatinine) should be performed until 7 days after drug onset.
Danish: Derfor skal der som en forsigtighedsregel udføres regelmæssig overvågning af nyrefunktionen efter administration af Cyanokit (herunder nitrogen og serumkreatinin) i 7 dage efter lægemidlet blev påbegyndt.
English: Because hydroxocobalamin will be administered in potentially life-threatening situations, breastfeeding is not a contraindication to its use.
Danish: Da hydroxocobalamin administreres i potentielt livstruende situationer, er amning ikke en kontraindikation.
English: This should be considered before haemodialysis is initiated in patients treated with hydroxocobalamin.
Danish: Der skal tages hensyn til dette, inden hæmodialyse påbegyndes hos patienter, som behandles med hydroxocobalamin.
English: Abdominal discomfort, dyspepsia, diarrhoea, vomiting, nausea, dysphagia.
Danish: Abdominalt ubehag, dyspepsi, diaré, opkastning, kvalme, dysfagi.
English: For the purpose of ambulatory use, Cyanokit may be exposed during short periods to the temperature variations of
Danish: Cyanokit kan, til ambulant brug, i korte perioder udsættes for temperaturudsving under
English: Oxalate crystals have been observed in the urine of healthy volunteers given hydroxocobalamin.
Danish: Der er blevet observeret oxalatkrystaller i urinen hos raske frivillige, som har fået hydroxocobalamin.
English: Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogens, including cyanogenic plants, aliphatic nitriles, or prolonged exposure to sodium nitroprusside.
Danish: Kilderne til cyanidforgiftning omfatter hydrogencyanid og dets salte, cyanogener, herunder cyanogene planter, alifatiske nitriler og langvarig eksponering for natriumnitroprussid.
English: Interference with burn assessment
Danish: Interferens med vurdering af forbrænding
English: However, skin lesions, oedema, and pain are highly suggestive of burns.
Danish: Hudlæsioner, ødem og smerte er dog kraftige tegn på en forbrænding.
English: If there is clinical suspicion of cyanide poisoning, it is strongly recommended that Cyanokit be administered without delay.
Danish: Ved klinisk mistanke om cyanidforgiftning anbefales det kraftigt, at Cyanokit administreres omgående.
English: Treatment decisions must be made on the basis of clinical history and/or signs and symptoms of cyanide intoxication.
Danish: Behandlingen fastlægges på baggrund af anamnese og/eller tegn og symptomer på cyanidforgiftning.
English: Headache; injection site reaction; peripheral oedema.
Danish: Hovedpine; reaktion på injektionsstedet; perifert ødem.
English: In general, the effectiveness of hydroxocobalamin in paediatric patients was similar to that of adults.
Danish: Generelt var virkningen af hydroxocobalamin blandt pædiatriske patienter sammenlignelig med den hos voksne.
English: Where neurological assessment over time was possible, (96 patients of the 171 patients who presented with neurological symptoms prior to hydroxocobalamin administration), 51 (53%) patients receiving hydroxocobalamin showed improvement or a complete restoration.
Danish: Hos de patienter, hvor en neurologisk vurdering var mulig i det tidsmæssige forløb (hos 96 af de 171 patienter, der havde neurologiske symptomer forud for administration af hydroxocobalamin), var der hos 51 (53 %) af patienterne, der fik hydroxocobalamin, en forbedring eller fuldstændig restitution af de neurologiske symptomer.
English: The pharmacokinetics of total cobalamins-(III) in this population may be affected by the body's cyanide load, since cyanocobalamin was reported to exhibit a 2-3 times lower half-life than total cobalamins-(III) in healthy volunteers.
Danish: Farmakokinetikken for de totale cobalamin-(III)-ioner kan i denne population være påvirket af kroppens cyanidbelastning, da cyanocobalamin blev rapporteret at have en 2-3 gange lavere halveringstid end de totale cobalamin-(III)-ioner hos raske frivillige.
English: Your doctor will recommend you to stop breast-feeding after treatment with Cyanokit.
Danish: Lægen vil anbefale, at du stopper amning efter behandling med Cyanokit.
English: For storage conditions of the reconstituted medicine, see 'Handling instructions' at the end of this package leaflet.
Danish: Opbevaringsforhold for det rekonstituerede lægemiddel: se 'Håndtering' til sidst i denne indlægsseddel.
English: Cyanokit is an antidote for the treatment of known or suspected cyanide poisoning in all age ranges.
Danish: Cyanokit er en modgift til behandling af kendt eller formodet cyanidforgiftning hos alle aldersgrupper.
English: Survival of cyanide-poisoned dogs
Danish: Overlevelsen af cyanidforgiftede hunde
English: Allergic reactions including angioneurotic oedema, skin eruption, urticaria and pruritus.
Danish: Allergiske reaktioner, herunder angioneurotisk ødem, hududslæt, urticaria og pruritus.
English: If blood products (whole blood, packed red cells, platelet concentrate and fresh frozen plasma) and hydroxocobalamin are administered simultaneously, use of separate intravenous lines (preferably on contralateral extremities) is recommended.
Danish: Hvis blodprodukter (fuldblod, røde blodlegemer, trombocytkoncentrat og frisk frosset plasma) og hydroxocobalamin administreres samtidig, anbefales det at bruge separate intravenøse adgange (helst på kontralaterale ekstremiteter).
English: Consequently, these and other medicinal products must not be administered simultaneously through the same intravenous line as hydroxocobalamin.
Danish: Disse og andre lægemidler må derfor ikke administreres samtidig med hydroxocobalamin gennem den samme intravenøse adgang.
English: The relevance of this finding to humans is unlikely since it was not reported in short-term studies conducted with hydroxocobalamin.
Danish: Dette vil næppe have relevans for mennesker, da det ikke blev rapporteret i kortvarige forsøg, hvor hydroxocobalamin blev undersøgt.
English: Among 144 patients not in initial cardiac arrest whose outcomes were known, 118 (82%) survived.
Danish: Blandt de 144 patienter, der ikke initialt havde haft hjertestop, og hvor udfaldet er kendt, overlevede 118 (82 %).
English: The Cyanokit vial is to be rocked or inverted for at least 30 seconds to mix the solution.
Danish: Cyanokit-hætteglasset skal vippes eller roteres i mindst 30 sekunder for at blande opløsningen.
English: One intravenous infusion set.
Danish: Et intravenøst infusionssæt.
English: Hydroxocobalamin may interfere with all urine colorimetric parameters.
Danish: Hydroxocobalamin kan interferere med alle kolorimetriske urinprøver.
English: The Cyanokit vial is to be rocked or inverted for at least 1 minute to mix the solution.
Danish: Cyanokit-hætteglasset skal vippes eller roteres i mindst 1 minut for at blande opløsningen.
English: Each hydroxocobalamin molecule can bind one cyanide ion by substituting the hydroxo ligand linked to the trivalent cobalt ion to form cyanocobalamin.
Danish: Hvert hydroxocobalamin-molekyle kan binde en cyanid-ion ved at erstatte hydroxo-liganden, der er bundet til den trivalente kobolt-ion, og danne cyanocobalamin.
English: The intravenous infusion set provided in the kit must then be used as it includes an appropriate filter and is to be primed with the reconstituted solution.
Danish: Derfor skal det intravenøse infusionssæt, der medfølger i pakningen, benyttes, da det indeholder et passende filter.
English: Before Cyanokit is administered, it is recommended to check affected persons for the presence of the following:
Danish: Før Cyanokit administreres, anbefales det at kontrollere, om den røgforgiftede person har:
English: The low molecular weight cobalamins-(III) formed including hydroxocobalamin are termed free cobalamins-(III); the sum of free and protein-bound cobalamins is termed total cobalamins-(III).
Danish: Disse cobalamin-(III)-ioner med lav molekylær vægt, herunder også hydroxocobalamin, kaldes frie cobalamin-(III)-ioner; summen af de frie og de proteinbundne cobalamin-ioner kaldes totale cobalamin-(III)-ioner.
English: Hydroxocobalamin will lower blood cyanide concentrations.
Danish: Hydroxocobalamin reducerer cyanidkoncentrationen i blodet.
English: - burn assessement.
Danish: brandsårsvurdering.
English: Hydroxocobalamin reduced whole blood cyanide concentrations from about 120 nmol/mL to 30-40 nmol/mL by the end of the infusion compared with 70 nmol/mL in dogs receiving sodium chloride 9 mg/mL alone.
Danish: Hydroxocobalamin reducerede alle cyanidkoncentrationerne i blodet fra omkring 120 nmol/ml til 30-40 nmol/ml hen mod afslutningen af infusionen, sammenlignet med 70 nmol/ml hos de hunde, der kun fik natriumchlorid 9 mg/ml.
English: Treatment of known or suspected cyanide poisoning in all age ranges.
Danish: Behandling ved kendt eller formodet cyanidforgiftning hos alle aldersgrupper.
English: In general, the effectiveness of hydroxocobalamin in these patients was similar to that of younger patients.
Danish: Blandt disse patienter var effektiviteten af hydroxocobalamin generelt sammenlignelig med den hos yngre patienter.
English: Cyanokit may interfere with burn assessment (red coloration of the skin) and laboratory tests and may lead to shut down of haemodialysis machines (see SmPC).”
Danish: Cyanokit kan interferere med vurderingen af forbrændinger (rødfarvning af huden) og laboratorieprøver og kan forårsage, at hæmodialysemaskiner lukker ned (jf. produktresuméet).”
English: The safety of administering other cyanide antidotes simultaneously with Cyanokit has not been established (see section 6.2).
Danish: Sikkerheden ved administration af andre cyanid-antidoter samtidig med Cyanokit, er ikke blevet påvist (se pkt.
English: This medicine is an emergency treatment.
Danish: Dette lægemiddel er beregnet til akutbehandling i nødstilfælde.
English: In the presence of the above signs, treatment with Cyanokit must not be delayed to obtain a plasma lactate concentration.
Danish: Ved tilstedeværelsen af ovennævnte tegn må behandlingen med Cyanokit ikke udsættes for først at måle lactatkoncentrationen i plasma.
English: Known hypersensitivity to hydroxocobalamin or vitamin B12 must be taken into benefit-risk consideration before administration of Cyanokit, since hypersensitive reactions may occur in patients receiving hydroxocobalamin (see section 4.8).
Danish: Hvis der er en kendt overfølsomhed over for hydroxocobalamin eller B12-vitamin, bør der foretages en risk/benefit-vurdering forud for administrationen af Cyanokit, da der kan forekomme overfølsomhedsreaktioner hos patienter, der får hydroxocobalamin (se pkt.
English: Common signs and symptoms of cyanide poisoning include: nausea, vomiting, headache, altered mental status (e.g. confusion, disorientation), chest tightness, dyspnoea, tachypnoea or hyperpnoea (early), bradypnoea or apnoea (late), hypertension (early) or hypotension (late), cardiovascular collapse, seizures or coma, mydriasis, and plasma lactate concentration > 8 mmol/L.
Danish: Almindelige tegn og symptomer på cyanidforgiftning inkluderer: kvalme, opkastning, hovedpine, ændret mental status (f.eks. forvirring og desorientering), trykken i brystet, dyspnø, takypnø eller hyperpnø (tidligt forløb), bradypnø eller apnø (sent forløb), hypertension (tidligt forløb) eller hypotension (sent forløb), kardiovaskulært kollaps, krampeanfald eller koma, mydriasis og en plasmalactatkoncentration på > 8 mmol/l.
English: Cyanokit may cause red discolouration of the plasma, which may cause artificial elevation or reduction in the levels of certain laboratory parameters (see section 4.4).
Danish: Cyanokit kan forårsage en rød misfarvning af plasma, som kan forårsage en kunstig stigning i eller reduktion af niveauet af visse laboratorieparametre (se pkt.
English: Sodium chloride 9 mg/mL (N=17)
Danish: Natriumchlorid 9 mg/ml (N=17)
English: Histopathology revealed brain lesions that were consistent with cyanide-induced hypoxia.
Danish: Histopatologien viste hjernelæsioner, der stemte overens med den cyanidinducerede hypoksi.
English: • most patients will experience a reversible red colouration of the skin and membranes lining body cavities (mucous membranes) that may last up to 15 days after administration of Cyanokit.
Danish: • de fleste patienter vil opleve en reversibel rødfarvning af huden og membranerne langs kroppens hulrum (slimhinderne), der kan vare i op til 15 dage efter administration af Cyanokit.
English: In the setting of multiple casualties such as terrorism or chemical disaster, panic symptoms including tachypnoea and vomiting may mimic early cyanide poisoning signs.
Danish: I katastrofetilfælde, f.eks. i forbindelse med terrorangreb eller kemikalieuheld, kan paniksymptomer, herunder takypnø og opkastning, ligne tidlige tegn på en cyanidforgiftning.
English: What you need to know before Cyanokit is used
Danish: Det skal du vide, før Cyanokit bruges
English: Cases of acute renal failure with acute tubular necrosis, renal impairment and urine calcium oxalate crystals present have been reported in patients treated with hydroxocobalamin following known or suspected cyanide poisoning.
Danish: Tilfælde af akut nyresvigt med akut tubulær nekrose, nedsat nyrefunktion og calciumoxalatkrystaller i urinen er blevet rapporteret hos patienter i behandling med hydroxocobalamin efter kendt eller formodet cyanidforgiftning.
English: • transport in the desert (4 days submitted to temperatures ranging from 5 to 60°C) and
Danish: • transport i ørkenen (4 dage med temperaturer mellem 5 °C og 60 °C) og
English: Preparation of Cyanokit
Danish: Klargøring af Cyanokit
English: monitoring of renal function: Cyanokit may lead to kidney failure and urine crystals.
Danish: overvågning af nyrefunktionen: Cyanokit kan føre til nyresvigt og krystaller i urinen.
English: • irregular heart beat
Danish: • uregelmæssig hjertebanken
English: When normalized for body weight, male and female subjects revealed no major differences in plasma and urinary pharmacokinetic parameters of free and total cobalamins-(III) following the administration of 5 g or 10 g Cyanokit.
Danish: Der blev, efter omregning i forhold til legemsvægt, ikke fundet nogen stor forskel blandt mænd og kvinder i de farmakokinetiske parametre for frie og totale cobalamin-(III)-ioner i urin og plasma efter administration af 5 g eller 10 g Cyanokit.
English: Coagulation
Danish: Koagulation
English: Treatment of cyanide poisoning must include immediate attention to airway patency, adequacy of oxygenation and hydration, cardiovascular support, and management of seizures.
Danish: Behandlingen af en cyanidforgiftning skal inkludere øjeblikkelig sikring af frie luftveje, tilstrækkelig ilt- og væsketilførsel, kardiovaskulær understøttelse og behandling af krampeanfald.
English: Because of its deep red colour, hydroxocobalamin has the potential to interfere with determination of laboratory parameters (e.g. clinical chemistry, haematology, coagulation, and urine parameters).
Danish: Da hydroxocobalamin er mørkerødt, kan det medføre en interferens i forbindelse med bestemmelse af laboratorieparametre (f.eks. klinisk kemi, hæmatologi, koagulation og urinparametre).
English: A total of 245 patients with suspected or known cyanide-poisoning were included in the clinical studies of the efficacy of hydroxocobalamin as an antidote.
Danish: I alt blev 245 patienter med formodet eller kendt cyanidforgiftning inkluderet i de kliniske studier, hvor effekten af hydroxocobalamin som antidot blev undersøgt.
English: Cyanokit is to be administered together with appropriate decontamination and supportive measures (see section 4.4).
Danish: Cyanokit skal administreres samtidig med, at der gennemføres passende dekontaminering og understøttende behandling (se pkt.
English: • fluid in the chest (pleural effusion)
Danish: • væske i brystet (pleural effusion)
English: In cyanide-poisoned patients, hydroxocobalamin is expected to bind cyanide to form cyanocobalamin, which is excreted in the urine.
Danish: Hos de cyanidforgiftede patienter forventes hydroxocobalamin at binde cyanid og danne cyanocobalamin, der herefter udskilles i urinen.
English: In anaesthetised rabbits, hydroxocobalamin exerted haemodynamic effects (increased mean arterial blood pressure and total peripheral resistance, decreased cardiac output) related to its nitric oxidescavenging property.
Danish: Hos bedøvede kaniner udviste hydroxocobalamin en hæmodynamisk påvirkning (en forhøjelse af det gennnemsnitlige arterielle blodtryk og af den totale perifere modstand, et fald i minutvolumen), som er relateret til dets evne til at udskille nitrogenoxid.
English: In particular, liver fibrosis was observed in dogs after administration of hydroxocobalamin for 4 weeks at 300 mg/kg.
Danish: Specielt blev der observeret leverfibrose hos hunde efter administration af 300 mg/kg hydroxocobalamin i 4 uger.
English: Simultaneous administration of hydroxocobalamin and blood products (whole blood, packed red cells, platelet concentrate and fresh frozen plasma) through the same intravenous line is not recommended.
Danish: Hydroxocobalamin bør ikke administreres samtidig med blodprodukter (fuldblod, røde blodlegemer, trombocytkoncentrat og frisk frosset plasma) gennem den samme intravenøse adgang.
English: For adults, the initial dose is 5 g. For children, it is 70 mg/kg body weight, up to a maximum dose of 5 g. If you need a second infusion, you will have it over 15 minutes to 2 hours.
Danish: Din første infusion af Cyanokit vil vare ca. 15 min. For voksne er den indledende dosis 5 g. For børn er den 70 mg/kg kropsvægt, op til en maksimal dosis på 5 g. Hvis du har brug for en yderligere infusion, vil den vare fra ca. 15 min. til 2 timer.
English: Approximately 50 known or suspected cyanide victims aged 65 or older received hydroxocobalamin in clinical studies.
Danish: Ca. 50 personer i alderen 65 eller derover med kendt eller formodet cyanidforgiftning fik hydroxocobalamin i kliniske studier.
English: Based on in vitro studies and pharmacokinetic data obtained in healthy volunteers the following table describes interference with laboratory tests that may be observed following a 5 g dose of hydroxocobalamin.
Danish: I følgende tabel beskrives, på baggrund af in vitro-studier og farmakokinetiske data fra raske frivillige, den interferens med laboratorieprøver, der muligvis kan observeres efter en hydroxocobalamin-dosis på 5 g. Efter en dosis på 10 g, kan interferensen forventes at vare i yderligere 24 timer.
English: Mean free and total cobalamins-(III) Cmax values of 113 and 579 µg eq/mL, respectively, were determined following a dose of 5 g Cyanokit (the recommended initial dose).
Danish: De gennemsnitlige Cmax-værdier for frie og totale cobalamin-(III)-ioner på hhv. 113 og 579 µg eq/ml blev påvist efter en dosis Cyanokit på 5 g (den anbefalede initiale dosis).
English: • breathing difficulties, hoarseness, difficulty in speaking
Danish: • vejrtrækningsbesvær, hæshed, talebesvær
English: Detailed instructions for your doctor or other health care professional on how to prepare the Cyanokit infusion and how to determine the dose can be found at the end of this package leaflet (see 'Handling instructions').
Danish: Der findes detaljerede oplysninger til din læge eller andet sundhedspersonale om, hvordan Cyanokitinfusionen klargøres og valg af dosis sidst i denne indlægsseddel (se 'Håndtering').
English: Cyanokit contains the active substance hydroxocobalamin.
Danish: Cyanokit indeholder det aktive stof hydroxocobalamin.
English: A decrease in blood pressure and a faster heart beat have also been observed in patients who have cyanide poisoning.
Danish: Der er også set fald i blodtrykket og hurtigere hjerteslag hos patienter med cyanidforgiftning.
English: Physical incompatibility (particle formation) was observed with the mixture of hydroxocobalamin reconstituted solution and the following medicinal products: diazepam, dobutamine, dopamine, fentanyl, nitroglycerin, pentobarbital, phenytoin sodium, propofol and thiopental.
Danish: Der blev observeret fysisk uforligelighed (partikeldannelse) ved blanding af rekonstitueret hydroxocobalamin og følgende lægemidler: diazepam, dobutamin, dopamin, fentanyl, glyceryltrinitrat, pentobarbital, phenytoin-natrium, propofol og thiopental.
English: • The active substance is hydroxocobalamin.
Danish: • Aktivt stof: hydroxocobalamin.
English: • Acute renal failure with acute tubular necrosis, renal impairment, urine calcium oxalate crystals present (see section 4.4).
Danish: • Akut nyresvigt med akut tubulær nekrose, nedsat nyrefunktion, calciumoxalatkrystaller til stede i urinen (se pkt.
English: • discomfort in your stomach
Danish: • ubehag i maven
English: • problems with memory
Danish: • hukommelsesproblemer
English: Reversible red colouration of the skin and mucous membranes : most patients will experience it up to 15 days after administration of Cyanokit.
Danish: Reversibel rødfarvning af hud og slimhinder: de fleste patienter vil opleve det i op til 15 dage efter administration af Cyanokit.