FrancophonIA/ELRC3.0 huggingface dataset:
English: No interference observed
Danish: Ingen interferens observeret
English: Unpredictable***
Danish: Uforudsigelig***
English: • altered mental status
Danish: • ændret mental status
English: One short catheter for administration to children.
Danish: Et kort kateter til administration til børn.
English: Such side effects may be serious and need immediate attention.
Danish: Sådanne bivirkninger kan være alvorlige og kræve øjeblikkelig lægehjælp.
English: The survival rate of 41% depended very much on the clinical situation.
Danish: Overlevelsesraten på 41 % afhang meget af det kliniske miljø.
English: The following side effects may be expected (frequency cannot be estimated from the available data):
Danish: De følgende bivirkninger kan forventes (hyppigheden kan ikke estimeres ud fra forhåndenværende data):
English: Body weight in kg
Danish: Legemsvægt i kg
English: Tell your doctor immediately if you have the following symptoms during or after this treatment:
Danish: Kontakt straks din læge, hvis du har følgende symptomer under eller efter behandlingen:
English: Cyanokit may modify the results of these tests.
Danish: Cyanokit kan ændre resultaterne af disse prøver.
English: Survival at Hour 4, N (%) 7 (41) Survival at Day 14, N (%) 3 (18)
Danish: Overlevelse efter 4 timer, N (%) 7 (41) Overlevelse efter 14 dage, N (%) 3 (18)
English: The liver and kidney were found to be the major target organs.
Danish: Lever og nyrer viste sig at være de vigtigste målorganer.
English: Repeat this procedure if necessary with the second vial.
Danish: Hvis det er nødvendigt, gentages denne procedure med det andet hætteglas.
English: * ≥ 10% interference observed on at least one analyser ** Artificially decreased using the diazo method *** Inconsistent results
Danish: * ≥ 10 % interferens observeret på mindst én analysator ** Kunstigt reduceret ved brug af diazo-metoden *** Inkonsistente resultater
English: No dose adjustment is required in these patients.
Danish: Det er ikke nødvendigt at justere dosis hos disse patienter.
English: Read all of this leaflet carefully before using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: Tell your doctor as soon as possible if you were pregnant or think you may have been pregnant during treatment with Cyanokit.
Danish: Fortæl det til din læge så hurtigt som muligt, hvis du var gravid eller tror, du kan have været gravid under behandlingen med Cyanokit.
English: Cyanide is a highly poisonous chemical.
Danish: Cyanid er et meget giftigt kemikalie.
English: However findings were only seen at exposure levels considered being higher than the maximum human exposure, indicating limited relevance to clinical use.
Danish: Disse fund blev dog kun observeret ved eksponeringsniveauer, der betragtes som værende højere end den maksimale humane eksponering, hvilket indikerer en begrænset relevans for den kliniske brug.
English: “To be attached to the patient's medical record:
Danish: “Skal påklæbes patientens journal:
English: From a microbiological point of view, the medicinal product should be used immediately.
Danish: Set fra et mikrobielt synspunkt skal lægemidlet anvendes omgående.
English: • changes in the results of blood tests for certain white blood cells (lymphocytes)
Danish: • forandrede resultater af blodprøver for visse hvide blodlegemer (lymfocytter)
English: Avenue Louise 480 1050 Brussels Belgium
Danish: Avenue Louise 480 1050 Brussels Belgien
English: • symptoms such as headache or dizziness, as they may be due to a rise in blood pressure.
Danish: • symptomer som hovedpine og svimmelhed, da de kan skyldes en stigning i blodtrykket.
English: Ventricular extrasystoles.
Danish: Ventrikulære extrasystoler.
English: However, because of the limitations of the available data, it is not possible to apply frequency estimations:
Danish: Som følge af de begrænsede data er det imidlertid ikke muligt at beregne hyppigheden:
English: • red colouration of the urine.
Danish: • Rødfarvning af urinen.
English: Duration of interference after a 5 g dose
Danish: Varighed af interferens efter en dosis på 5 g
English: Pharmacotherapeutic group: Antidotes, ATC code: V03AB33
Danish: Farmakoterapeutisk klassifikation: Antidoter, ATC-kode: V03AB33
English: Decrease in the percentage of lymphocytes.
Danish: Fald i procentdelen af lymfocytter.
English: 40 avenue George V 75008 Paris France
Danish: 40 Avenue George V 75008 Paris Frankrig
English: Documentation on efficacy is available for 54 paediatric patients.
Danish: Der er dokumentation for virkningen fra 54 pædiatriske patienter.
English: • inflammation in the part of the body where the medicine was infused.
Danish: • betændelse det sted på kroppen, hvor infusionen med medicin blev indgivet.
English: Artificially increased*
Danish: Kunstigt øget*
English: • exposure to fire smoke in an enclosed area
Danish: • været udsat for røggasser i et lukket rum
English: There are no adequate data from the use of hydroxocobalamin in pregnant women and the potential risk for humans is unknown.
Danish: Der findes ingen adækvate data om anvendelsen af hydroxocobalamin til gravide, og den potentielle risiko for mennesker er ukendt.
English: Overall, the total urinary excretion was calculated to be at least 60 to 70% of the administered dose.
Danish: Den samlede totale udskillelse i urinen blev beregnet til at være mindst 60 til 70 % af den administrerede dosis.
English: Prothrombin time (PT) Quick or INR
Danish: Protrombintid (PT) Quick eller INR
English: Cyanokit may lead to shut down of haemodialysis machines until it is eliminated from the blood (at least 5.5 to 6.5 days).
Danish: Cyanokit kan føre til, at hæmodialysemaskinen lukker ned, indtil det elimineres fra blodet (mindst 5,5 til 6,5 dage).
English: Activated partial thromboplastin time (aPTT)
Danish: Aktiveret partiel tromboplastintid (APTT)
English: The dose of 150 mg/kg approximately corresponds to the maximum recommended human dose.
Danish: Dosen på 150 mg/kg svarer nogenlunde til den maksimalt anbefalede dosis til mennesker.
English: Due to ethical considerations, no controlled human efficacy studies have been performed.
Danish: Af etiske grunde er der ikke blevet gennemført kontrollerede studier over virkning blandt mennesker.
English: These may last for several weeks, and affect mainly the face and the neck.
Danish: Dette kan vare i flere uger og viser sig især på ansigt og hals.
English: Limited data on children (0 to 18 years old) treated with hydroxocobalamin did not show any difference in the safety profile of hydroxocobalamin between adults and children.
Danish: Begrænsede data fra børn (i alderen 0 til 18 år), der blev behandlet med hydroxocobalamin, viste ingen forskel i hydroxocobalamins sikkerhedsprofil for voksne og børn.
English: It can be administered during pregnancy and breast-feeding.
Danish: Det kan anvendes under graviditet og amning.
English: Doses as high as 15 g have been administered without reported specific dose related adverse reactions.
Danish: Der er blevet administreret doser på op til 15 g uden rapportering af specifikke, dosisrelaterede bivirkninger.
English: The maximal increase in blood pressure has been observed toward the end of infusion (see section 4.8).
Danish: Den maksimale forhøjelse af blodtrykket er blevet observeret hen mod infusionens afslutning (se pkt.
English: The majority of the urinary excretion occurred during the first 24 hours, but red coloured urine was observed for up to 35 days following the intravenous infusion.
Danish: Størstedelen af udskillelsen i urinen fandt sted inden for de første 24 timer, men der blev observeret rødfarvet urin i op til 35 dage efter den intravenøse infusion.
English: Simultaneous administration of Cyanokit and other products
Danish: Samtidig administration af Cyanokit og andre produkter
English: The effects on these tests typically last 48 hours after a 5 g dose, but may persist for longer periods.
Danish: Virkningen på disse prøver varer typisk 48 timer efter en dosis på 5 g, men kan vare længere.
English: Subsequent dose
Danish: Efterfølgende dosis
English: In-use stability of the reconstituted solution
Danish: Stabilitet af den rekonstituerede opløsning
English: Caution is required in the interpretation of urinary colorimetric tests for as long as chromaturia is present.
Danish: Der skal udvises forsigtighed ved fortolkning af kolorimetriske urinprøver, så længe kromaturi er tilstede.
English: Initial dose in g in mL
Danish: Initialdosis i g i ml
English: Two transfer devices.
Danish: To overføringskanyler.
English: Cyanokit does not substitute oxygen therapy and must not delay the set up of the above measures.
Danish: Cyanokit er ikke en erstatning for iltterapi og må ikke forsinke iværksættelsen af de ovenfor anførte tiltag.
English: 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 Marketing Authorisation Holder and/or Health Authorities and to carefully follow-up on the pregnancy and its outcome.
Danish: 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/eller sundhedsmyndighederne og nøje følge op på graviditeten og dens gennemførelse.
English: Read the leaflet for storage conditions in ambulatory use
Danish: Læs indlægssedlen vedrørende opbevaringsbetingelser ved ambulant anvendelse.
English: Do not use this medicine after the expiry date which is stated on the vial, the cardboard box and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på hætteglasset, papæsken og pakningen efter EXP.
English: • that you have been treated with Cyanokit if you need to have the following: - any blood or urine tests.
Danish: • hvis du er blevet behandlet med Cyanokit og du skal have taget følgende: blod- eller urinprøver.
English: • soot present around mouth, nose and/or oropharynx
Danish: • sod omkring mund, næse og/eller oropharynx
English: No data are available on male and female fertility as well as on peri- and postnatal development.
Danish: Der findes hverken data angående mandlig og kvindelig fertilitet eller data om den præ- og postnatale udvikling.
English: Adults: The maximum total recommended dose is 10 g.
Danish: Voksne: Den maksimale totale anbefalede dosis er 10 g.
English: This rise in blood pressure especially occurs at the end of having this treatment and usually settles down within several hours
Danish: Denne stigning i blodtrykket vil især forekomme hen mod afslutningen af behandlingen og vil almindeligvis forsvinde igen inden for nogle timer
English: Hydroxocobalamin has not been evaluated for carcinogenic potential.
Danish: Hydroxocobalamin er ikke blevet vurderet med henblik på kræftfremkaldende potentiale.
English: • swelling around the eyes, lips, tongue, throat or hands
Danish: • hævelse omkring øjne, læber, tunge, hals eller hænder
English: Because the reconstituted solution is a dark red solution, some insoluble particles may not be seen.
Danish: Da den rekonstituerede opløsning er mørkerød, er det muligt, at nogle uopløselige partikler måske ikke ses.
English: The presence of altered mental status (confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning.
Danish: Tilstedeværelsen af ændret mental status (forvirring og desorientering) og/eller mydriasis er tegn på en reel cyanidforgiftning.
English: Of the 89 patients who died, 63 were initially found in cardiac arrest, suggesting that many of these patients had almost certainly suffered irreparable brain injury prior to administration of hydroxocobalamin.
Danish: Af de 89 patienter, der døde, var 63 blevet fundet med hjertestop, hvilket kan tyde på, at mange af disse patienter næsten med sikkerhed havde lidt uoprettelig skade på hjernen forud for administration af hydroxocobalamin.
English: Creatinine Total and conjugate bilirubin** Triglycerides Cholesterol Total protein Glucose Albumin Alkaline phosphatase
Danish: Kreatinin Total og konjugeret bilirubin** Triglycerider Kolesterol Total protein Glucose Albumin Alkalisk fosfatase
English: • a feeling of tightness in the throat
Danish: • en følelse af sammensnøring i halsen
English: Of the 213 patients in whom the outcome was known the survival was 58%.
Danish: Hos 213 af de patienter, hvor udfaldet er kendt, overlevede 58 %.
English: Artificially decreased*
Danish: Kunstigt reduceret*
English: • if you are allergic to hydroxocobalamin or vitamin B12.
Danish: • hvis du er allergisk over for hydroxocobalamin eller B12-vitamin.
English: Laboratory parameter
Danish: Laboratorieparametre
English: Observed in vitro interferences of hydroxocobalamin with laboratory tests
Danish: Observeret in vitro-interferens af hydroxocobalamin med laboratorieprøver
English: The rate of intravenous infusion for the second dose ranges from 15 minutes (for patients extremely unstable) to 2 hours based on patient condition.
Danish: Infusionshastigheden for den efterfølgende dosis varierer fra 15 min. (for de patienter, hvis tilstand er ekstremt ustabil) til 2 timer, afhængigt af patientens tilstand.
English: Increase in blood pressure
Danish: Forhøjet blodtryk
English: Consideration must be given to decontamination measures based on the route of exposure.
Danish: Det er vigtigt, at metoden til dekontaminering udvælges afhængigt af eksponeringsvejen.
English: • Cyanide-poisoned patients
Danish: • Cyanidforgiftede patienter
English: This kit does not contain diluent.
Danish: Dette kit indeholder ikke solvens.
English: The extent and duration of interference in cyanide-poisoned patients may differ according to the severity of intoxication.
Danish: Omfanget og varigheden af denne interferens kan, hos cyanid-forgiftede patienter, være forskellig i henhold til graden af intoksikation.
English: Use with other cyanide antidotes
Danish: Brug med andre cyanid-antidoter
English: Animal studies have shown teratogenic effects following daily exposure throughout organogenesis (see section 5.3).
Danish: Dyreforsøg har påvist teratogen virkning efter daglig eksponering under organogenesen (se pkt.
English: However, taken into account: - that no more than two injections of hydroxocobalamin are to be administered, - the potentially life threatening condition, - the lack of alternative treatment, hydroxocobalamin may be given to a pregnant woman.
Danish: Når det imidlertid tages i betragtning: - at der ikke skal administreres mere end to injektioner hydroxocobalamin, - at tilstanden er potentielt livstruende, - at der ikke findes nogen alternativ behandling, kan hydroxocobalamin gives til gravide.
English: Lactate dehydrogenase (LDH)
Danish: Lactatdehydrogenase (LDH)
English: The maximum total recommended dose is 10 g for adults, and 140 mg/kg in children up to a maximum of 10 g.
Danish: Den maksimale totale anbefalede dosis er 10 g for voksne og 140 mg/kg for børn, op til et maksimum på 10 g.
English: The remaining 102 subjects were healthy volunteers who had not been exposed to cyanide at the time of hydroxocobalamin administration.
Danish: De resterende 102 forsøgspersoner var raske frivillige, som ikke havde været udsat for cyanid på det tidspunkt, hvor hydroxocobalamin blev administreret.
English: The presence and extent of cyanide poisoning are often initially unknown.
Danish: Ofte erkendes tilstedeværelsen og graden af en cyanidforgiftning ikke i begyndelsen.
English: No studies on fertility have been performed (see section 5.3).
Danish: Der er ikke blevet udført studier af påvirkning af fertiliteten (se pkt.
English: Memory impairment; dizziness.
Danish: Hukommelsessvigt; svimmelhed.
English: Dose-proportional pharmacokinetics were observed following single dose intravenous administration of 2.5 to 10 g of Cyanokit in healthy volunteers.
Danish: Den dosisproportionale farmakokinetik blev observeret efter administration af en enkelt intravenøs dosis på 2,5 til 10 g Cyanokit hos raske frivillige.
English: Your doctor or health care professional will give you Cyanokit by infusion into a vein.
Danish: En læge eller sundhedspersonalet vil give dig Cyanokit ved infusion gennem en blodåre.
English: Signs and symptoms of cyanide poisoning
Danish: Tegn og symptomer på cyanidforgiftning
English: Allergy (hypersensitivity)
Danish: Allergi (overfølsomhed)
English: Haemodialysis may be effective in such a circumstance, but is only indicated in the event of significant hydroxocobalamin-related toxicity.
Danish: Hæmodialyse kan være effektivt i denne situation, men er kun indiceret i tilfælde af en signifikant hydroxocobalamin-relateret toksicitet.
English: Dark red crystalline powder.
Danish: Mørkerødt krystallinsk pulver.
English: • coloured plasma, which may cause artificial elevation or reduction in the levels of certain laboratory parameters.
Danish: • farvet blodplasma, som kan føre til en kunstig stigning i eller reduktion af niveauerne på visse laboratorieprøver.
English: Centre de Production de Semoy 2, rue du Pressoir Vert F-45400 Semoy France
Danish: Centre de Production de Semoy 2, rue du Pressoir Vert F-54400 Semoy Frankrig
English: 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).
Danish: Cyanokit kan, til ambulant brug, i korte perioder udsættes for temperaturudsving under almindelig transport (15 dage med temperaturer mellem 5 °C og 40 °C), transport i ørkenen (4 dage med temperaturer mellem 5 °C og 60 °C) og nedfrysnings-/optøningscyklusser (15 dage med temperaturer mellem -20 °C og 40 °C).
English: The effectiveness of hydroxocobalamin was examined in a controlled study in cyanide-poisoned adult dogs.
Danish: Hydroxocobalamins effektivitet blev undersøgt i et kontrolleret forsøg med cyanidforgiftede, voksne hunde.
English: Heart and blood pressure problems
Danish: Hjerte og blodtryk
English: Transient increase in blood pressure, usually resolving within several hours; hot flush.
Danish: Midlertidig stigning i blodtrykket, der almindeligvis forsvinder inden for nogle timer; hedestigninger.
English: They will have to take it into account before treating you with Cyanokit.
Danish: Det skal de tage med i deres overvejelser, inden de behandler dig med Cyanokit.
English: The following adverse reactions have been reported in association with Cyanokit use.
Danish: Følgende bivirkninger er blevet rapporteret i forbindelse med brugen af Cyanokit.
English: Cyanocobalamin is a stable, non-toxic compound that is excreted in the urine.
Danish: Cyanocobalamin er et stabilt, ugiftigt stof, der udskilles i urinen.
English: In some situations, hemodialysis was required to achieve recovery (see section 4.8).
Danish: I nogle situationer var det nødvendigt med hæmodialyse for at opnå bedring (se pkt.
English: Furthermore, in 34 patients with known cyanide concentrations above the lethal threshold (≥ 100 µmol/L), 21 (62%) survived following treatment with hydroxocobalamin.
Danish: 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.
English: Not all smoke inhalation victims necessarily will have cyanide poisoning, but may present with burns, trauma, and exposure to additional toxic substances aggravating the clinical picture.
Danish: Ikke alle røgforgiftede har nødvendigvis en cyanidforgiftning, men kan have forbrændinger, traumer og kan have været udsat for andre toksiske stoffer, hvilket forværrer det kliniske billede.
English: Initial dose of Cyanokit is administered as an intravenous infusion over 15 minutes.
Danish: Den initiale dosis af Cyanokit administreres som en intravenøs infusion i løbet af 15 min.
English: Depending upon the severity of the poisoning and the clinical response, a second dose may be administered
Danish: Afhængigt af forgiftningens sværhedsgrad og den kliniske respons kan der administreres en efterfølgende dosis.
English: Combination with another cyanide antidote: Chemical incompatibility was observed with sodium thiosulfate and sodium nitrite.
Danish: Kombination med en anden cyanid-antidot: Der blev observeret kemisk uforligelighed med natriumthiosulfat og natriumnitrit.
English: Cyanokit may interfere with the assessment as it causes red coloration of the skin.
Danish: Cyanokit kan påvirke vurderingen, da det forårsager en rødfarvning af huden.
English: 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 8°C.
Danish: Hvis det ikke anvendes omgående, er opbevaringstid og -forhold før brug brugerens ansvar og vil normalt ikke overskride 6 timer ved 2 °C til 8 °C.
English: 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.
Danish: Den hurtige og fuldstændige restitution af hæmodynamiske virkninger og derefter af blodgasser, pH og lactat efter cyanidforgiftningen var sandsynligvis medvirkende til det bedre resultat blandt de hydroxocobalamin-behandlede dyr.
English: Tell your doctor or other health care professional
Danish: Fortæl det til lægen eller sundhedspersonalet
English: Out of the 20 paediatric patients without initial cardiac arrest, 18 (90%) survived, of whom 4 with sequelae.
Danish: Af de 20 pædiatriske patienter, som ikke initialt havde hjertestop, overlevede 18 (90 %), heraf 4 med sequelae.
English: Cyanokit has been administered to this patient.
Danish: Denne patient har fået administreret cyanokit.
English: It must not be shaken as shaking the vial may cause foam and therefore may make checking reconstitution less easy.
Danish: Det må ikke rystes, da rystelse af hætteglasset kan medføre skumdannelse, hvilket kan besværliggøre kontrol af opløsningen.
English: 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 acidaemia) are highly suggestive of cyanide poisoning.
Danish: I så fald vil hypotension og/eller en plasmalactatkoncentration 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.
English: Developmental toxicity, including teratogenicity, was observed in rats and rabbits at dose levels of 150 mg/kg and higher administered daily throughout organogenesis.
Danish: Udviklingstoksicitet, herunder teratogenicitet, blev observeret hos rotter og kaniner ved dosisniveauer på 150 mg/kg og derover, der blev administreret dagligt under organogenesen.
English: Dogs were poisoned by intravenous administration of a lethal dose of potassium cyanide.
Danish: Hundene blev forgiftet ved intravenøs administration af en dødelig dosis cyankalium.
English: While determination of blood cyanide concentration is not required and must not delay treatment with hydroxocobalamin, it may be useful for documenting cyanide poisoning.
Danish: Selvom det ikke er påkrævet at påvise cyanidkoncentrationen i blodet, og dette på ingen måde må føre til, at behandlingen med hydroxocobalamin udsættes, kan det være nyttigt til at dokumentere en cyanidforgiftning.