natgillin/translations-raw huggingface dataset:
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 plasmalaktatkoncentration 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.
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.
Tilstedeværelsen af ændret mental status (forvirring og desorientering) og/ eller mydriasis er tegn på en reel cyanidforgiftning.
The presence of altered mental status (confusion and disorientation) and/ or mydriasis is suggestive of true cyanide poisoning.
Før Cyanokit administreres, anbefales det at kontrollere, om den røgforgiftede person har: • været udsat for røggasser i et lukket rum • sod omkring mund, næse og/ eller oropharynx • ændret mental status
Before Cyanokit is administered, it is recommended to check affected persons for the presence of the following: • exposure to fire smoke in an enclosed area • soot present around mouth, nose and/ or oropharynx • altered mental status
3 I så fald vil hypotension og/ eller en plasmalaktatkoncentration på ≥ 10 mmol/ l (højere end den, der er nævnt under tegn og symptomer, da kulmonoxid bidrager til metabolisk acidose) være kraftige tegn på en cyanidforgiftning.
In this setting hypotension and/ or a plasma lactate concentration ≥ 10 mmol/ l (higher than the one mentioned under signs and symptoms due to the fact that carbon monoxide contributes to lactic
Ved tilstedeværelsen af ovennævnte tegn må behandlingen med Cyanokit ikke udsættes for først at måle laktatkoncentrationen i plasma.
In the presence of the above signs, treatment with Cyanokit must not be delayed to obtain a plasma lactate concentration.
4. 8).
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).
Det forhøjede blodtryk er reversibelt og for det meste asymptomatisk.
The maximal increase in blood pressure has been observed toward the end of infusion.
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).
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, koncentrationen af forskellige cobalamin - (III) - ioner, herunder cyanocobalamin, og til dels tiden fra prøvetagning til faktisk måling.
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.
I følgende tabel beskrives, på baggrund af in vitro- undersøgelser og farmakokinetiske data fra raske frivillige, den interferens med laboratorieprøver, der muligvis kan observeres efter en hydroxocobalamin- dosis på 5 g.
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.
Efter en dosis på 10 g, kan interferensen forventes at vare i yderligere 24 timer.
Interference following a 10 g dose can be expected to last up to an additional 24 hours.
Resultaterne kan variere betydeligt imellem forskellige analysatorer.
The extent and duration of interference in cyanide-poisoned patients may differ according to the severity of intoxication.
Observeret in vitro- interferens af hydroxocobalamin med laboratorieprøver
Observed in vitro interferences of hydroxocobalamin with laboratory tests
Ingen interferens
No interference
Kunstigt
Duration of
interferens efter
Laboratory parameter
parametre
observed
Kunstigt øget *
Artificially increased*
reduceret *
Artificially decreased*
Uforudsigelig ***
Unpredictable***
en dosis på 5 g
interference after a 5 g dose
Calcium Natrium Kalium Klorid
Calcium Sodium Potassium Chloride Urea Gamma glutamyl transferase (GGT)
Kreatinin Total og konjugeret bilirubin **
Creatinine Total and conjugate bilirubin** Triglycerides Cholesterol Total protein Glucose Albumin Alkaline
Alaninamino - transferase (ALAT) Amylase
Alanine aminotransferase (ALT) Amylase
Fosfat Urinsyre Aspartatamino - transferase (ASAT)
Phosphate Uric acid Aspartate aminotransferase (AST) Creatine kinase (CK) Creatinine kinase isoenzym MB (CKMB) Lactate dehydrogenase
4 Varighed af Laboratorie -
4
Kunstigt øget *
Artificially increased* phosphatase
Uforudsigelig ***
Unpredictable*** (LDH)
Erytrocytter Hæmatokrit Middelcellevolumen (MCV) Leukocytter Lymfocytter Monocytter Eosinofile Neutrofile Trombocytter
Erythrocytes Haematocrit Mean corpuscular volume (MCV) Leucocytes Lymphocytes Monocytes Eosinophils Neutrophils Platelets
Hæmoglobin (Hb) Middelcelle - hæmoglobin (MCH) Middelcelle - hæmoglobin - koncentration (MCHC)
Haemoglobin (Hb) Mean corpuscular haemoglobin (MCH) Mean corpuscular haemoglobin concentration (MCHC)
12- 16 timer
12-16 hours
Koagulation
Coagulation * ≥ 10% interference observed on at least one analyser ** Artificially decreased using the diazo method *** Inconsistent results
Aktiveret partiel tromboplastintid (APTT) Protrombintid (PT) Quick eller INR
Activated partial thromboplastin time (aPTT) Prothrombin time (PT) Quick or INR
* ≥ 10% interferens observeret på mindst én analysator ** Kunstigt reduceret ved brug af diazo- metoden *** Inkonsistente resultater Anvendte analysatorer:
Analysers used:
Brug med andre cyanid- antidoter
Use with other cyanide antidotes
6. 2).
The safety of administering other cyanide antidotes simultaneously with Cyanokit has not been established (see section 6.2).
6. 2).
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 (see section 6.2).
5. 3).
Animal studies have shown teratogenic effects following daily exposure throughout organogenesis (see section 5.3).
- at der ikke skal administreres mere end to injektioner hydroxocobalamin,
- that no more than two injections of hydroxocobalamin are to be administered,
- at tilstanden er potentielt livstruende,
- the potentially life threatening condition,
- at der ikke findes nogen alternativ behandling,
- the lack of alternative treatment,
kan hydroxocobalamin gives til gravide.
hydroxocobalamin may be given to a pregnant woman.
I tilfælde af kendt graviditet på tidspunktet for behandlingen med Cyanokit eller i tilfælde af, at graviditeten bliver kendt efter behandlingen med Cyanokit, opfordres sundhedspersonalet til straks at rapportere eksponeringen under graviditeten til indehaveren af markedsføringstilladelsen og nøje følge op på graviditeten og dens gennemførelse.
In case of known pregnancy at the time of treatment with Cyanokit or in case that pregnancy becomes known after treatment with Cyanokit, health care professionals are requested to promptly report the exposure during pregnancy to the Market Authorisation Holder and to carefully follow-up on the pregnancy and its outcome.
5 Da hydroxocobalamin administreres i potentielt livstruende situationer, er amning ikke en kontraindikation.
5 Because hydroxocobalamin will be administered in potentially life-threatening situations, breast- feeding is not a contraindication to its use.
Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
No studies on the effects on the ability to drive or to use machines have been performed.
I alt blev hydroxocobalamin testet hos 347 forsøgspersoner i kliniske undersøgelser.
A total of 347 subjects were exposed to hydroxocobalamin in clinical studies.
De følgende bivirkninger er blevet rapporteret i forbindelse med brugen af Cyanokit.
The following undesirable effects have been reported in association with Cyanokit use.
Som følge af de begrænsede data, er det imidlertid ikke muligt at beregne hyppigheden:
However, because of the limitations of the available data, it is not possible to apply frequency estimations:
4. 4).
Cyanokit may cause red discolouration of the plasma, which may cause artificial elevation or reduction in the levels of certain laboratory parameters (see section 4.5).
6 Hud og subkutane væv
Skin and subcutaneous tissue disorders
Reversibel rødfarvning af hud og slimhinder (se ovenfor).
6 Reversible red colouration of the skin and mucous membranes (see above).
Hæmodialyse kan være effektivt i denne situation, men er kun indiceret i tilfælde af en signifikant hydroxocobalamin- relateret toksicitet.
Haemodialysis may be effective in such a circumstance, but is only indicated in the event of significant hydroxocobalamin- related toxicity.
Antidot, ATC- kode:
Antidote, ATC code:
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.
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.
Af etiske grunde er der ikke blevet gennemført kontrollerede effektforsøg blandt mennesker.
Due to ethical considerations, no controlled human efficacy studies have been performed.
Derefter fik hundene natriumklorid 9 mg/ ml, 75 mg/ kg eller 150 mg/ kg hydroxocobalamin, der blev administreret intravenøst i 7, 5 min.
Dogs then received sodium chloride 9 mg/ ml, 75 mg/ kg or 150 mg/ kg hydroxocobalamin, administered intravenously over 7.5 minutes.
5. 2].
The 75 mg/ kg and 150 mg/ kg doses are approximately equivalent to 5 g and 10 g of hydroxocobalamin, respectively, in humans, not only on a body weight basis but also on Cmax basis of hydroxocobalamin [total cobalamins-(III), see section 5.2].
7 Overlevelsesraten efter 4 timer og efter 14 dage var væsentlig højere i de dosisgrupper, der fik hydroxocobalamin 75 mg/ kg og 150 mg/ kg, sammenlignet med de hunde, der kun fik natriumklorid 9 mg/ ml:
Survival at hour 4 and at day 14 was significantly greater in 75 mg/ kg and 150 mg/ kg hydroxocobalamin dose groups compared with dogs receiving sodium chloride 9 mg/ ml alone:
Overlevelsen af cyanidforgiftede hunde
7 Survival of cyanide-poisoned dogs
Hydroxocobalamin
Hydroxocobalamin
9 mg/ ml
9 mg/ ml
75 mg/ kg
75 mg/ kg
150 mg/ kg
150 mg/ kg
Parameter Overlevelse efter 4 timer, N (%) Overlevelse efter 14 dage, N (%)
Parameter Survival at Hour 4, N (%) Survival at Day 14, N (%)
(N=19) 18 (95) * 15 (79) *
(N=19) 18 (95)* 15 (79)*
(N=18) 18 (100) * 18 (100) *
(N=18) 18 (100)* 18 (100)*
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 natriumklorid.
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.
Den hurtige og fuldstændige restitution af hæmodynamiske virkninger og derefter af blodgasser, pH og laktat efter cyanidforgiftningen var sandsynligvis medvirkende til det bedre resultat blandt de hydroxocobalamin- behandlede dyr.
The rapid and complete recovery of haemodynamics and subsequently of blood gases, pH, and lactate after cyanide poisoning likely contributed to the better outcome of the hydroxocobalamin-treated animals.
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 natriumklorid 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.
I alt blev 245 patienter med formodet eller kendt cyanidforgiftning inkluderet i de kliniske undersøgelser, 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.
Hos 213 af de patienter, hvor udfaldet er kendt, overlevede 58%.
Of the 213 patients in whom the outcome was known the survival was 58%.
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.
Derudover var der blandt 34 patienter med en kendt cyanid- koncentration, der lå over den dødelige grænse (≥ 100 µmol/ l), 21 (62%) der overlevede efter behandling med hydroxocobalamin.
Furthermore, in 34 patients with known cyanide concentrations above the lethal threshold (≥ 100 µmol/ l), 21 (62%) survived following treatment with hydroxocobalamin.
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.
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.
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.
50 personer i alderen 65 eller derover med kendt eller formodet cyanidforgiftning fik hydroxocobalamin i kliniske undersøgelser.
Approximately 50 known or suspected cyanide victims aged 65 or older received hydroxocobalamin in clinical studies.
• Pædiatriske patienter
• Paediatric patients
Der er dokumentation for virkningen fra 54 pædiatriske patienter.
Documentation on efficacy is availablefor 54 paediatric patients.
120 mg/ kg legemsvægt.
The mean age of the paediatric patients was about six years and the mean dose of hydroxocobalamin was about 120 mg/ kg body weight.
Overlevelsesraten på 41% afhang meget af det kliniske miljø.
The survival rate of 41% depended very much on the clinical situation.
Af de 20 pædiatriske patienter, som ikke initialt havde hjertestop, overlevede 18 (90%), heraf 4 med sequelae.
Out of the 20 paediatric patients without initial cardiac arrest, 18 (90%) survived, of whom 4 with sequelae.
8 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
Disse fortrænger hydroxoliganden, og der dannes forskellige cobalamin - (III) - komplexer.
The low molecular weight cobalamins-(III) formed including
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.
8 hydroxocobalamin are termed free cobalamins-(III); the sum of free and protein-bound cobalamins is termed total cobalamins-(III).
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).
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).
Den dosisproportionale farmakokinetik blev observeret efter administration af en enkelt intravenøs dosis på 2, 5 til 10 g Cyanokit hos raske frivillige.
Dose-proportional pharmacokinetics were observed following single dose intravenous administration of 2.5 to 10 g of Cyanokit in healthy volunteers.
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).
197 og 995 µg eq/ ml påvist efter en dosis Cyanokit på 10 g.
Similarly, mean free and total cobalamins-(III) Cmax values of 197 and 995 µg eq/ ml, respectively, were determined following the dose of 10 g Cyanokit.
26 til 31 timer ved et dosisniveau på 5 og 10 g.
The predominant mean half-life of free and total cobalamins-(III) was approximately 26 to 31 hours at the 5 and 10 g dose level.
50% af en dosis på 10 g Cyanokit.
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.
Den samlede totale udskillelse i urinen blev beregnet til at være mindst 60 til 70% af den administrerede dosis.
Overall, the total urinary excretion was calculated to be at least 60 to 70% of the administered dose.
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.
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.
Der blev ikke identificeret nogen særlige risici for mennesker på baggrund af konventionelle undersøgelser, hvor toksicitet og genotoksicitet blev undersøgt for en enkeltdosis eller gentagne doser.
No special hazard for humans was identified based on conventional studies of single and repeated dose toxicity and genotoxicity.
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.
Udviklingstoksicitet, herunder teratogenicitet, blev observeret hos rotter og kaniner ved dosisniveauer på 150 mg/ kg og derover, der blev administreret dagligt under organogenesen.
Developmental toxicity, including teratogenicity, was observed in rats and rabbits at dose levels of 150 mg/ kg and higher administered daily throughout organogenesis.
Dosen på 150 mg/ kg svarer nogenlunde til den maksimalt anbefalede dosis til mennesker.
The dose of 150 mg/ kg approximately corresponds to the maximum recommended human dose.
Der findes hverken data angående mandlig og kvindelig fertilitet eller data om den præ - og postnatale udvikling.
No data are available on male and female fertility as well as on peri- and postnatal development.
Der blev observeret fysisk inkompatibilitet (partikeldannelse) med blandingen af det opløste hydroxocobalamin og de følgende lægemidler: diazepam, dobutamin, dopamin, fentanyl, nitroglycerin, pentobarbital, phenytoin- natrium, propofol og thiopental.
Physical incompatibility (particle formation) was observed with the mixture of hydroxocobalamin in solution and the following medicinal products: diazepam, dobutamine, dopamine, fentanyl, nitroglycerin, pentobarbital, phenytoin sodium, propofol and thiopental.
Der blev observeret kemisk inkompatibilitet med natriumthiosulfat og natriumnitrit, og der er rapporteret kemisk inkompatibilitet med ascorbinsyre.
Chemical incompatibility was observed with sodium thiosulfate, sodium nitrite, and has been reported with ascorbic acid.
Disse lægemidler må derfor ikke administreres samtidig med hydroxocobalamin gennem den samme intravenøse adgang.
Consequently, these medicinal products must not be administered simultaneously through the same intravenous line as hydroxocobalamin.
6. 6).
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 (see section 6.6).
Der er påvist kemisk og fysisk stabilitet af den rekonstituerede opløsning i 6 timer ved en temperatur på mellem 2°C og 40°C.
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 6 hours at a temperature between 2°C and 40°C.
Set ud fra et mikrobielt synspunkt skal lægemidlet anvendes omgående.
From a microbiological point of view, the product should be used immediately.
Hvis det ikke anvendes omgående, er opbevaringstid og - forhold før brug brugerens ansvar og bør normalt ikke overstige 6 timer ved 2°C - 8°C.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hours at 2°C to 8ºC.
Cyanokit kan, til ambulant brug, i korte perioder udsættes for temperaturudsving under almindelig transport (15 dage med temperaturer på 5°C til 40°C), transport i ørkenen (4 dage med temperaturer på 5°C til 60°C), og nedfrysnings - / optøningscyklusser (15 dage med temperaturer på - 20°C til 40°C).
For the purpose of ambulatory use, Cyanokit may be exposed during short periods to the temperature variations of usual transport (15 days submitted to temperatures ranging from 5°C to 40°C), transport in the desert (4 days submitted to temperatures ranging from 5°C to 60°C) and freezing/ defrosting cycles (15 days submitted to temperatures ranging from -20°C to 40°C).
Farveløse type II- hætteglas, 250 ml, som er lukket med en bromobutylgummiprop og et aluminiumslåg med en plastikmembran.
Type II colourless 250 ml glass vial closed with bromobutyl rubber stopper and an aluminium cap with a plastic lid.
Hvert hætteglas indeholder 2, 5 g pulver til infusionsvæske, opløsning.
Each vial contains 2.5 g powder for solution for infusion.