natgillin/translations-raw huggingface dataset:
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.
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.
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.
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.
Lægen vil anbefale, at du stopper amning efter behandling med Cyanokit.
Your doctor will recommend you to stop breast-feeding after treatment with Cyanokit.
Opbevaringsforhold for det rekonstituerede lægemiddel: se 'Håndtering' til sidst i denne indlægsseddel.
For storage conditions of the reconstituted medicine, see 'Handling instructions' at the end of this package leaflet.
Cyanokit er en modgift til behandling af kendt eller formodet cyanidforgiftning hos alle aldersgrupper.
Cyanokit is an antidote for the treatment of known or suspected cyanide poisoning in all age ranges.
Overlevelsen af cyanidforgiftede hunde
Survival of cyanide-poisoned dogs
Allergiske reaktioner, herunder angioneurotisk ødem, hududslæt, urticaria og pruritus.
Allergic reactions including angioneurotic oedema, skin eruption, urticaria and pruritus.
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).
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.
Disse og andre lægemidler må derfor ikke administreres samtidig med hydroxocobalamin gennem den samme intravenøse adgang.
Consequently, these and other medicinal products must not be administered simultaneously through the same intravenous line as hydroxocobalamin.
Dette vil næppe have relevans for mennesker, da det ikke blev rapporteret i kortvarige forsøg, hvor hydroxocobalamin blev undersøgt.
The relevance of this finding to humans is unlikely since it was not reported in short-term studies conducted with hydroxocobalamin.
Blandt de 144 patienter, der ikke initialt havde haft hjertestop, og hvor udfaldet er kendt, overlevede 118 (82 %).
Among 144 patients not in initial cardiac arrest whose outcomes were known, 118 (82%) survived.
Cyanokit-hætteglasset skal vippes eller roteres i mindst 30 sekunder for at blande opløsningen.
The Cyanokit vial is to be rocked or inverted for at least 30 seconds to mix the solution.
Et intravenøst infusionssæt.
One intravenous infusion set.
Hydroxocobalamin kan interferere med alle kolorimetriske urinprøver.
Hydroxocobalamin may interfere with all urine colorimetric parameters.
Cyanokit-hætteglasset skal vippes eller roteres i mindst 1 minut for at blande opløsningen.
The Cyanokit vial is to be rocked or inverted for at least 1 minute to mix the solution.
Hvert hydroxocobalamin-molekyle kan binde en cyanid-ion ved at erstatte hydroxo-liganden, der er bundet til den trivalente kobolt-ion, og danne cyanocobalamin.
Each hydroxocobalamin molecule can bind one cyanide ion by substituting the hydroxo ligand linked to the trivalent cobalt ion to form cyanocobalamin.
Derfor skal det intravenøse infusionssæt, der medfølger i pakningen, benyttes, da det indeholder et passende filter.
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.
Før Cyanokit administreres, anbefales det at kontrollere, om den røgforgiftede person har:
Before Cyanokit is administered, it is recommended to check affected persons for the presence of the following:
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.
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).
Hydroxocobalamin reducerer cyanidkoncentrationen i blodet.
Hydroxocobalamin will lower blood cyanide concentrations.
brandsårsvurdering.
- burn assessement.
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.
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.
Behandling ved kendt eller formodet cyanidforgiftning hos alle aldersgrupper.
Treatment of known or suspected cyanide poisoning in all age ranges.
Blandt disse patienter var effektiviteten af hydroxocobalamin generelt sammenlignelig med den hos yngre patienter.
In general, the effectiveness of hydroxocobalamin in these patients was similar to that of younger patients.
Cyanokit kan interferere med vurderingen af forbrændinger (rødfarvning af huden) og laboratorieprøver og kan forårsage, at hæmodialysemaskiner lukker ned (jf. produktresuméet).”
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).”
Sikkerheden ved administration af andre cyanid-antidoter samtidig med Cyanokit, er ikke blevet påvist (se pkt.
The safety of administering other cyanide antidotes simultaneously with Cyanokit has not been established (see section 6.2).
Dette lægemiddel er beregnet til akutbehandling i nødstilfælde.
This medicine is an emergency treatment.
Ved tilstedeværelsen af ovennævnte tegn må behandlingen med Cyanokit ikke udsættes for først at måle lactatkoncentrationen i plasma.
In the presence of the above signs, treatment with Cyanokit must not be delayed to obtain a plasma lactate concentration.
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.
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).
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.
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.
Cyanokit kan forårsage en rød misfarvning af plasma, som kan forårsage en kunstig stigning i eller reduktion af niveauet af visse laboratorieparametre (se pkt.
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).
Natriumchlorid 9 mg/ml (N=17)
Sodium chloride 9 mg/mL (N=17)
Histopatologien viste hjernelæsioner, der stemte overens med den cyanidinducerede hypoksi.
Histopathology revealed brain lesions that were consistent with cyanide-induced hypoxia.
• 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.
• 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.
I katastrofetilfælde, f.eks. i forbindelse med terrorangreb eller kemikalieuheld, kan paniksymptomer, herunder takypnø og opkastning, ligne tidlige tegn på en cyanidforgiftning.
In the setting of multiple casualties such as terrorism or chemical disaster, panic symptoms including tachypnoea and vomiting may mimic early cyanide poisoning signs.
Det skal du vide, før Cyanokit bruges
What you need to know before Cyanokit is used
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.
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.
• transport i ørkenen (4 dage med temperaturer mellem 5 °C og 60 °C) og
• transport in the desert (4 days submitted to temperatures ranging from 5 to 60°C) and
Klargøring af Cyanokit
Preparation of Cyanokit
overvågning af nyrefunktionen: Cyanokit kan føre til nyresvigt og krystaller i urinen.
monitoring of renal function: Cyanokit may lead to kidney failure and urine crystals.
• uregelmæssig hjertebanken
• irregular heart beat
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.
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.
Koagulation
Coagulation
Behandlingen af en cyanidforgiftning skal inkludere øjeblikkelig sikring af frie luftveje, tilstrækkelig ilt- og væsketilførsel, kardiovaskulær understøttelse og behandling af krampeanfald.
Treatment of cyanide poisoning must include immediate attention to airway patency, adequacy of oxygenation and hydration, cardiovascular support, and management of seizures.
Da hydroxocobalamin er mørkerødt, kan det medføre en interferens i forbindelse med bestemmelse af laboratorieparametre (f.eks. klinisk kemi, hæmatologi, koagulation og urinparametre).
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).
I alt blev 245 patienter med formodet eller kendt cyanidforgiftning inkluderet i de kliniske studier, hvor effekten af hydroxocobalamin som antidot blev undersøgt.
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.
Cyanokit skal administreres samtidig med, at der gennemføres passende dekontaminering og understøttende behandling (se pkt.
Cyanokit is to be administered together with appropriate decontamination and supportive measures (see section 4.4).
• væske i brystet (pleural effusion)
• fluid in the chest (pleural effusion)
Hos de cyanidforgiftede patienter forventes hydroxocobalamin at binde cyanid og danne cyanocobalamin, der herefter udskilles i urinen.
In cyanide-poisoned patients, hydroxocobalamin is expected to bind cyanide to form cyanocobalamin, which is excreted in the urine.
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.
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.
Specielt blev der observeret leverfibrose hos hunde efter administration af 300 mg/kg hydroxocobalamin i 4 uger.
In particular, liver fibrosis was observed in dogs after administration of hydroxocobalamin for 4 weeks at 300 mg/kg.
Hydroxocobalamin bør ikke administreres samtidig med blodprodukter (fuldblod, røde blodlegemer, trombocytkoncentrat og frisk frosset plasma) gennem den samme intravenøse adgang.
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.
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.
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.
Ca. 50 personer i alderen 65 eller derover med kendt eller formodet cyanidforgiftning fik hydroxocobalamin i kliniske studier.
Approximately 50 known or suspected cyanide victims aged 65 or older received hydroxocobalamin in clinical studies.
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.
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.
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).
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).
• vejrtrækningsbesvær, hæshed, talebesvær
• breathing difficulties, hoarseness, difficulty in speaking
Der findes detaljerede oplysninger til din læge eller andet sundhedspersonale om, hvordan Cyanokitinfusionen klargøres og valg af dosis sidst i denne indlægsseddel (se 'Håndtering').
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').
Cyanokit indeholder det aktive stof hydroxocobalamin.
Cyanokit contains the active substance hydroxocobalamin.
Der er også set fald i blodtrykket og hurtigere hjerteslag hos patienter med cyanidforgiftning.
A decrease in blood pressure and a faster heart beat have also been observed in patients who have cyanide poisoning.
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.
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.
• Aktivt stof: hydroxocobalamin.
• The active substance is hydroxocobalamin.
• Akut nyresvigt med akut tubulær nekrose, nedsat nyrefunktion, calciumoxalatkrystaller til stede i urinen (se pkt.
• Acute renal failure with acute tubular necrosis, renal impairment, urine calcium oxalate crystals present (see section 4.4).
• ubehag i maven
• discomfort in your stomach
• hukommelsesproblemer
• problems with memory
Reversibel rødfarvning af hud og slimhinder: de fleste patienter vil opleve det i op til 15 dage efter administration af Cyanokit.
Reversible red colouration of the skin and mucous membranes : most patients will experience it up to 15 days after administration of Cyanokit.
Da hydroxocobalamin har en dyb rød farve, kan det forårsage, at hæmodialysemaskiner lukker ned på grund af en fejlagtigt detekteret 'blodlækage'.
Because of its deep red color, hydroxocobalamin may cause haemodialysis machines to shut down due to an erroneous detection of a ‘blood leak'.
Rastløshed.
Restlessness.
Hvis det besluttes at administrere en anden cyanid-antidot sammen med Cyanokit, må disse lægemidler ikke administreres samtidig gennem samme intravenøse adgang.
If the decision is made to administer another cyanide antidote with Cyanokit, these medicinal products must not be administered concurrently in the same intravenous line.
Aspartataminotransferase (ASAT) Kreatinkinase (CK) Kreatinkinaseisoenzym MB (CKMB)
Creatine kinase (CK) Creatine kinase isoenzym MB (CKMB)
Der blev observeret et fald i blodtrykket hos cyanidforgiftede patienter.
A decrease in blood pressure was observed in cyanide-poisoned patients.
Pleural effusion, dyspnø, tæthedsfornemmelse i halsen, tør hals, ubehag i brystet.
Pleural effusion, dyspnoea, throat tightness, dry throat, chest discomfort.
Cyanokit indeholder:
What Cyanokit contains
Cyanidforgiftning kan opstå som følge af udsættelse for røggasser (brand) i lukkede rum, inhalation, indtagelse eller dermal eksponering.
Cyanide poisoning may result from exposure to smoke from closed space fires, inhalation, ingestion, or dermal exposure.
Da hydroxocobalamin er mørkerødt, kan det føre til en rødfarvning af huden og kan derfor interferere med vurderingen af forbrændinger.
Because of its deep red colour, hydroxocobalamin has the potential to induce a red colouration of the skin and therefore may interfere with burn assessment.
Der skal derfor udvises forsigtighed, når resultaterne af disse laboratorieprøver rapporteres og fortolkes.
Results may vary considerably from one analyser to another, therefore, caution is required when reporting and interpreting laboratory results.
Der blev observeret kemisk uforligelighed ved blanding af rekonstitueret hydroxocobalamin og følgende lægemidler: adrenalin, lidocainhydrochlorid, adenosin, atropin, midazolam, ketamin, succinylcholinchlorid, amiodaronhydrochlorid, natriumhydrogencarbonat, natriumthiosulfat samt natriumnitrit, og det er blevet rapporteret med ascorbinsyre.
Chemical incompatibility was observed with the mixture of hydroxocobalamin reconstituted solution and the following medicinal products: epinephrine, lidocaine hydrochloride, adenosine, atropine, midazolam, ketamin, succinylcholine chloride, amiodarone hydrochloride, sodium bicarbonate, sodium thiosulfate, sodium nitrite, and has been reported with ascorbic acid.
Der er påvist kemisk og fysisk stabilitet af den rekonstituerede opløsning med natriumchlorid 9 mg/ml (0,9 %) i 6 timer ved en temperatur på mellem 2 °C og 40 °C.
Chemical and physical in-use stability of the reconstituted solution with sodium chloride 9 mg/mL (0.9%) has been demonstrated for 6 hours at a temperature between 2°C and 40°C.
• nedfrysnings-/optøningscyklusser (15 dage med temperaturer mellem -20 °C og 40 °C)
• freezing/defrosting cycles (15 days submitted to temperatures ranging from -20 to 40°C).
• nyreskader, såsom akut nedsat nyrefuntkion og krystaller i urinen.
• kidney injuries such as acute kidney impairment and urine crystals.
• Kromaturi: urinen vil hos alle patienten få en ret markant rød farve i løbet af de første 3 dage efter administration.
• Chromaturia: all patients will show a dark red colouration of the urine quite marked during the first three days following administration.
In vitro-prøver indikerer, at graden og varigheden af denne interferens afhænger af en række faktorer, som f.eks. doseringen af hydroxocobalamin, analyten, analytkoncentrationen, metoden, analysatoren,
In vitro tests indicate that the extent and duration of the interference is dependant on numerous factors such as the dose of hydroxocobalamin, analyte, analyte concentration, methodology, analyser, concentrations of cobalamins-(III) including cyanocobalamin and partially the time between sampling and measurement.
(Boehringer Mannheim), CellDyn 3700 (Abbott), Clinitek 500 (Bayer), Cobas Integra 700, 400 (Roche), Gen-S Coultronics, Hitachi 917, STA Compact, Vitros 950 (Ortho Diagnostics)
Analysers used: ACL Futura (Instrumentation Laboratory), Axsym/Architect (Abbott), BM Coasys (Boehringer Mannheim), CellDyn 3700 (Abbott), Clinitek 500 (Bayer), Cobas Integra 700, 400 (Roche), Gen-S Coultronics, Hitachi 917, STA
Hævelse, irritation, rødme.
Swelling, irritation, redness.
Alaninaminotransferase (ALAT) Amylase
Alanine aminotransferase (ALT)
• almindelig transport (15 dage med temperaturer mellem 5 °C og 40 °C)
• usual transport (15 days submitted to temperatures ranging from 5 to 40°C)
Der findes detaljerede oplysninger til din læge eller andet sundhedspersonale om, hvordan Cyanokit anvendes sammen med anden medicin sidst i denne indlægsseddel (se 'Håndtering').
Detailed information for your doctor or other health care professional regarding simultaneous administration of Cyanokit with other medicines can be found at the end of this package leaflet (see 'Handling instructions').
I alt blev hydroxocobalamin testet hos 347 forsøgspersoner i kliniske studier.
A total of 347 subjects were exposed to hydroxocobalamin in clinical studies.
Sådan skal Cyanokit bruges
How Cyanokit is used
Hydroxocobalamins virkning ved behandling af cyanidforgiftning er baseret på, at det kan binde cyanid-ioner med en høj bindingsstyrke.
The action of hydroxocobalamin in the treatment of cyanide poisoning is based on its ability to tightly bind cyanide ions.
Der blev observeret en stigning i hjertefrekvensen hos cyanidforgiftede patienter.
An increase in heart rate was observed in cyanide-poisoned patients.
En overføringskanyle.
One transfer device.
Incidensen af hjernelæsioner var markant lavere hos de hunde, der fik 150 mg/kg hydroxocobalamin sammenlignet med de hunde, der fik 75 mg/kg hydroxocobalamin eller 9 mg/ml natriumchlorid.
The incidence of brain lesions was markedly lower in dogs having received 150 mg/kg hydroxocobalamin than in dogs having received 75 mg/kg hydroxocobalamin or sodium chloride 9 mg/mL.
• rødme i ansigtet (hedestigning).
• redness of the face (flush).
Behandlingen med Cyanokit skal foretages samtidig med, at der gennemføres passende afgiftning og understøttende behandling.
Cyanokit is to be administered together with appropriate decontamination and supportive measures.
Hvis man alligevel ønsker at påvise cynanidniveauet i blodet, anbefales det, at blodprøven tages, før behandlingen med Cyanokit indledes.
However, if a cyanide blood level determination is planned, it is recommended to draw the blood sample before initiation of treatment with Cyanokit.
• hævelse, irritation, rødme.
• swelling, irritation, redness.
Urinen kan blive ved med at være farvet i op til 35 dage efter behandlingen med Cyanokit.
Urine colouration may last up to 35 days after administration of Cyanokit.
Alle patienter får en stærk rødfarvning af urinen i de første tre dage efter behandlingen.
All patients will show a dark red colouration of the urine quite marked during the first three days following administration.
Monocytter
Monocytes
• hævede ankler
• swelling of ankles