FrancophonIA/ELRC3.0 huggingface dataset:
English: Use with caution when administering Zycortal concurrently with medicinal products which affect either serum sodium or potassium concentrations, or cellular transportation of sodium or potassium, for example: trimethoprim, amphotericin B, digoxin or insulin.
Danish: Udvis forsigtighed når Zycortal administreres samtidigt med lægemidler, der kan påvirke koncentrationerne af enten serum-natrium eller -kalium eller celletransporten af natrium eller kalium, f.eks.: trimethoprim, amphotericin B, digoxin eller insulin.
English: ratio (i.e. 27 to 32) on Day 25, adjust the dose based on the Day 10 Na⁺/K⁺ ratio using the guidelines in Table 1, below.
Danish: +-forhold (dvs. 27 til 32) på dag 25, justeres dosis baseret på Na⁺/K⁺-forholdet på dag 10 ved hjælp af retningslinierne i Tabel 1 herunder.
English: Second dose of Zycortal: At approximately 25 days after the first dose, re-evaluate the dog and measure the Na⁺/K⁺ ratio.
Danish: Anden dosis af Zycortal: Hunden evalueres igen ca. 25 dage efter den første dosis og Na⁺/K⁺-forholdet måles.
English: Table 1: Day 25: Administering the Second Dose of Zycortal If the Day 10 Na⁺/K⁺ ratio is:
Danish: Tabel 1: Dag 25: Administrering af anden dosis af Zycortal Hvis Na⁺/K⁺forholdet på dag 10 er:
English: If irritation occurs, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Ved overfølsomhed over for lægemidlet, skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: • If the dog is clinically normal and has a Na⁺/K⁺ ratio > 32 on Day 25, either adjust the dose based on the Day 10 Na⁺/K⁺ ratio according to Table 1 or delay the dose (see Prolonging the dosing interval).
Danish: • Hvis hunden er klinisk normal og har et normalt Na⁺/K⁺-forhold > 32 på dag 25, justeres dosis enten baseret på Na⁺/K⁺-forholdet på dag 10 i overensstemmelse med Tabel 1 eller dosis udskydes (se Forlængelse af doseringsintervallet).
English: At approximately 25 days after the first dose, re-evaluate the dog and measure the Na⁺/K⁺ ratio.
Danish: Hunden evalueres igen ca. 25 dage efter den første dosis og Na⁺/K⁺-forholdet måles.
English: Sodium chloride Chlorocresol
Danish: Natriumchlorid
English: Decrease dose to: 2.1 mg/kg body weight
Danish: Nedsæt dosis til: 2,1 mg/kg kropsvægt
English: In the clinical trial, the mean final dose of desoxycortone pivalate was 1.9 mg/kg (range 1.22.5 mg/kg) and the mean final dosing interval was 38.7 ± 12.7 days (range 20-99 days) with the majority of dogs having a dosing interval between 20 and 46 days.
Danish: I det kliniske studie var den middel endelige dosis desoxycorton pivalat 1,9 mg/kg (interval 1,22,5 mg/kg), og det middel endelige doseringsinterval var 38,7 ± 12,7 dage (interval 20-99 dage).
English: The osmotic gradient promotes water absorption from the renal tubules resulting in increased extracellular fluid volume, leading to blood volume expansion, improved venous return to the heart, and increased cardiac output.
Danish: Den osmotiske gradient fremmer vandabsorption fra de renale tubuli, hvilket resulterer i øget ekstracellulær væskemængde.
English: Pack size of 1.
Danish: Pakning med 1 hætteglas.
English: Pregnant and breast-feeding women should avoid administration of this product.
Danish: Lægemidlet bør ikke administreres af gravide og ammende kvinder.
English: Prolonged-release suspension for injection.
Danish: Depotinjektionsvæske, suspension.
English: SPECIAL WARNING(S)
Danish: SÆRLIG(E) ADVARSEL
English: Active substance: Desoxycortone pivalate 25 mg/ml
Danish: Aktivt stof: Desoxycorton pivalat 25 mg/ml
English: PHARMACEUTICAL PARTICULARS
Danish: FARMACEUISKE OPLYSNINGER
English: desoxycortone pivalate 25 mg/ml
Danish: desoxycorton pivalat 25 mg/ml
English: PACKAGE LEAFLET: Zycortal 25 mg/ml prolonged-release suspension for injection for dogs
Danish: INDLÆGSSEDDEL: Zycortal 25 mg/ml depotinjektionsvæske, suspension, til hunde
English: In the clinical trial, the mean final dose of Zycortal was 1.9 mg/kg (range 1.2-2.5 mg/kg) and the mean final dosing interval was 38.7 ± 12.7 days (range 20-99 days) with the majority of dogs having a dosing interval between 20 and 46 days.
Danish: 2,5 mg/kg), og middel endelige doseringsinterval var 38,7 ± 12,7 dage (interval 20-99 dage).
English: Zycortal 25 mg/ml prolonged-release suspension for injection desoxycortone pivalate
Danish: Zycortal 25 mg/ml depotinjektionsvæske, suspension desoxycorton pivalat
English: CARDBOARD CARTON
Danish: PAPKARTON
English: Zycortal 25 mg/ml prolonged-release suspension for injection for dogs Desoxycortone pivalate
Danish: Zycortal 25 mg/ml depotinjektionsvæske, suspension, til hunde desoxycorton pivalat
English: Zycortal 25 mg/ml prolonged-release suspension for injection for dogs desoxycortone pivalate
Danish: Zycortal 25 mg/ml depotinjektionsvæske, suspension, til hunde Desoxycorton pivalat
English: Zycortal 25 mg/ml prolonged-release suspension for injection for dogs
Danish: Zycortal 25 mg/ml depotinjektionsvæske, suspension, til hunde
English: 25 days after the first dose, administer Zycortal, as follows: Decrease dose to: 2.0 mg/kg body weight
Danish: 25 dage efter den første dosis administreres Zycortal som følger:
English: Invented name Strength Pharmaceutical form
Danish: Særnavn Styrke Lægemiddelform
English: Route of administration Packaging Content
Danish: Emballage Indhold
English: Fifty of the patients in this study survived.
Danish: Halvtreds af patienterne i undersøgelsen overlevede.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cyanokit on 31 November 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cyanokit den 31. november 2007.
English: The full EPAR for Cyanokit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Cyanokit findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The second dose is given over a period of between 15 minutes and two hours, depending on the patient's condition.
Danish: Den anden dosis gives over et tidsrum på mellem 15 minutter og to timer, afhængigt af patientens tilstand.
English: The information on these patients was obtained from their medical notes, as recorded in databases at two French hospitals.
Danish: Oplysningerne om disse patienter blev hentet fra deres journaler, således som de var registreret i databaserne på to franske hospitaler.
English: This is a summary of the European public assessment report (EPAR) for Cyanokit.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cyanokit.
English: Symptoms of brain damage resolved in 38 of 66 patients.
Danish: Symptomerne på hjerneskade svandt hos 38 af 66 patienter.
English: It is given as an infusion over 15 minutes.
Danish: Det gives ved en infusion af 15 minutters varighed.
English: Other information about Cyanokit
Danish: Andre oplysninger om Cyanokit
English: A risk management plan has been developed to ensure that Cyanokit is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Cyanokit anvendes så sikkert som muligt.
English: Hydroxocobalamin (vitamin B12a) has been used as a vitamin supplement since the 1950s.
Danish: Hydroxocobalamin (vitamin B12a) har været anvendt som vitamintilskud siden 1950'erne.
English: In the study of smoke inhalation, the response to Cyanokit was assessed as ‘positive' in 31 patients (45%), ‘partial' in 15 (22%) and ‘absent' in 10 (15%).
Danish: I undersøgelsen med indånding af røg blev patienternes reaktion på Cyanokit vurderet med betegnelsen "positiv" hos 31 patienter (45 %), "delvis positiv" hos 15 (22 %) og "ingen" hos 10 (15 %).
English: The maximum total dose is 10 g for adults, and 140 mg/kg in children up to a maximum of 10 g.
Danish: Den maksimale samlede dosis til voksne er 10 g. Til børn er den maksimale samlede dosis 140 mg/kg, dog i alt højst 10 g.
English: Because hydroxocobalamin has an intense red colour, most patients will have dark red colouring of the skin and mucous membranes for up to 15 days and of the urine for up to 35 days after receiving Cyanokit.
Danish: Da hydroxocobalamin har en stærk rød farve, vil de fleste patienter få stærk rødfarvning af hud og slimhinder i indtil 15 dage og af urinen i indtil 35 dage efter at have fået Cyanokit.
English: Cyanokit is given as an emergency treatment as soon as possible after poisoning.
Danish: Cyanokit gives som akutbehandling snarest muligt efter forgiftningen.
English: For more information about treatment with Cyanokit, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Cyanokit, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For adults, the initial dose is 5 g. For children, it is 70 mg per kilogram body weight up to a maximum dose of 5 g. A second dose can be given, depending on how severe the poisoning is and how well the patient is responding.
Danish: Til voksne er begyndelsesdosis 5 g. Til børn anvendes 70 mg pr. kg legemsvægt, i alt dog højst 5 g. Derudover kan der gives endnu en dosis afhængigt af, hvor svær forgiftningen er, og hvor godt behandlingen virker.
English: This can be attached to the patient's notes so that hospital staff are made aware of these effects of the medicine.
Danish: Mærkaten kan indsættes i patientjournalen, så sygehuspersonalet bliver gjort opmærksom på disse virkninger af lægemidlet.
English: What measures are being taken to ensure the safe and effective use of Cyanokit?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cyanokit?
English: This helps to reduce the effects of cyanide poisoning.
Danish: Derved afbødes virkningerne af cyanidforgiftningen.
English: The CHMP concluded that Cyanokit appeared to be a well-tolerated and efficient cyanide antidote, based on its effects on survival and the prevention of brain damage.
Danish: CHMP konkluderede, at Cyanokit synes at være en veltolereret og effektiv modgift mod cyanid, baseret på dets indvirkning på overlevelsen og forebyggelsen af hjerneskade.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Cyanokit.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Cyanokit skal anvendes.
English: It contains the active substance hydroxocobalamin (vitamin B12a).
Danish: Det indeholder det aktive stof hydroxocobalamin (vitamin B12a).
English: The response was unknown in the remaining 13 patients.
Danish: For de resterende 13 patienter blev det ikke oplyst, hvordan de reagerede.
English: In this study, the patients' condition at the accident scene was compared with that at the end of the infusion of Cyanokit and over the following three days.
Danish: I denne undersøgelse blev patienternes tilstand på uheldsstedet sammenlignet med deres tilstand efter infusionen af Cyanokit og i de efterfølgende tre dage.
English: However, the CHMP concluded that Cyanokit had advantages over alternative antidotes because it has a good safety profile in patients who have not been poisoned.
Danish: CHMP konkluderede imidlertid, at Cyanokit havde fordele frem for alternative modgifte, fordi det har en god sikkerhedsprofil hos patienter, der ikke er forgiftet.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cyanokit, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Cyanokit, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: There have been no studies directly comparing Cyanokit to any other treatment in humans.
Danish: Der er ikke udført undersøgelser, der direkte sammenligner Cyanokit med andre lægemidler hos mennesker.
English: The active substance in Cyanokit, hydroxocobalamin, reacts with cyanide in the body to form cyanocobalamin, a non-poisonous compound that is removed from the body in the urine.
Danish: Det aktive stof i Cyanokit, hydroxocobalamin, reagerer med cyanid i kroppen, hvorved der dannes cyanocobalamin, en ugiftig forbindelse, der udskilles af kroppen gennem urinen.
English: The frequency of the other side effects of Cyanokit cannot be estimated with the information currently available.
Danish: Hyppigheden af de øvrige bivirkninger af Cyanokit kan ikke vurderes ud fra de foreliggende oplysninger.
English: Two patients survived despite their hearts having stopped before receiving Cyanokit.
Danish: To patienter overlevede, skønt de fik hjertestop, før de fik Cyanokit.
English: Cyanokit is given along with other appropriate decontamination and supportive measures, including providing oxygen for the patient to breathe.
Danish: Cyanokit gives sammen med anden passende sanerende og støttende behandling, herunder ilt til indånding.
English: This makes it a useful option when cyanide poisoning is only suspected.
Danish: Det kan derfor være nyttigt, når der kun er mistanke om cyanidforgiftning.
English: In one study of 69 patients, cyanide poisoning was due to exposure to smoke from fire.
Danish: Én undersøgelse omfattede 69 patienter med cyanidforgiftning som følge af udsættelse for røg fra ildebrande.
English: Cyanide poisoning usually results from exposure to smoke from fire, from breathing or swallowing cyanide, or from getting it onto the skin or mucous membranes (moist body surfaces, such as the lining of the mouth).
Danish: Cyanidforgiftning skyldes sædvanligvis udsættelse for røg ved ildebrand, indånding eller indtagelse af cyanid eller optagelse af cyanid fra huden eller slimhinderne (f.eks. i munden).
English: What is the risk associated with Cyanokit?
Danish: Hvilken risiko er der forbundet med Cyanokit?
English: Information on its effectiveness was obtained in 83 patients who had been admitted to hospital with suspected cyanide poisoning and who received Cyanokit.
Danish: Oplysningerne om virkningen af Cyanokit blev hentet fra 83 patienter, der var indlagt på mistanke om cyanidforgiftning, og som fik Cyanokit.
English: Of the 14 patients whose cyanide exposure was due to something other than smoke inhalation, 10 survived, including seven patients with ‘lethal' levels of cyanide in the blood.
Danish: Af de 14 patienter med cyanidforgiftning af anden årsag end indånding af røg overlevede de 10, af hvilke syv havde "dødelige" koncentrationer af cyanid i blodet.
English: Therefore, the CHMP decided that Cyanokit's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Derfor besluttede CHMP, at fordelene ved Cyanokit opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Cyanokit.
English: This lowers cyanide levels in the body and stops the cyanide fixing itself to an enzyme in cells called cytochrome oxidase, which is important for providing energy in cells.
Danish: Dette mindsker cyanidindholdet i kroppen og standser bindingen af cyanid til enzymet cytokromoxidase, der findes i cellerne og er vigtigt for deres energiproduktion.
English: Survival was more likely in those who received Cyanokit before their hearts had stopped, who had less severe symptoms of brain damage and who had lower blood cyanide levels.
Danish: Overlevelsesprocenten var størst hos dem, der fik Cyanokit, før de fik hjertestop, dem, der havde mindre svære symptomer på hjerneskade, og dem med lavere cyanidindhold i blodet.
English: The use of Cyanokit can interfere with the assessment of burns and with laboratory test results.
Danish: Når en patient har fået Cyanokit, kan det gribe ind i vurderingen af eventuelle forbrændinger og i resultaterne af patientens laboratorieprøver.
English: Why has Cyanokit been approved?
Danish: Hvorfor blev Cyanokit godkendt?
English: The four who died had high blood levels of cyanide, and either their hearts had stopped or they had stopped breathing before receiving Cyanokit.
Danish: De fire, der døde, havde et højt cyanidindhold i blodet og fik enten hjertestop eller vejrtrækningsstop, før de fik Cyanokit.
English: Cyanokit is a powder to be made up into a solution for infusion (drip) into a vein.
Danish: Cyanokit er et pulver, der opløses og indgives ved infusion (dråbetilførsel) i en vene.
English: What is Cyanokit?
Danish: Hvad er Cyanokit?
English: Cyanokit is used as an antidote to treat known or suspected poisoning with cyanide, a highly poisonous chemical.
Danish: Cyanokit anvendes som modgift ved kendt eller formodet cyanidforgiftning.
English: For the full list of all side effects reported with Cyanokit, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Cyanokit fremgår af indlægssedlen.
English: A sticker explaining this is supplied with every pack of Cyanokit.
Danish: Med hver pakning af Cyanokit følger en klæbemærkat, der oplyser herom.
English: What is Cyanokit used for?
Danish: Hvad anvendes Cyanokit til?
English: How has Cyanokit been studied?
Danish: Hvordan blev Cyanokit undersøgt?
English: What benefit has Cyanokit shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Cyanokit?
English: There is no information available on success rates with other antidotes for cyanide poisoning, so it was not possible to carry out a comparison between the success rates seen with Cyanokit and with alternatives.
Danish: Der foreligger ikke oplysninger om succesraten med andre modgifte til anvendelse ved cyanidforgiftning.
English: How is Cyanokit used?
Danish: Hvordan anvendes Cyanokit?
English: A further 14 patients were studied whose cyanide poisoning was due to something other than smoke inhalation; most of these patients had taken cyanide during a suicide attempt.
Danish: Derudover undersøgtes 14 patienter med cyanidforgiftning af anden årsag end indånding af røg.
English: How does Cyanokit work?
Danish: Hvordan virker Cyanokit?
English: (see Annex I).
Danish: (se bilag I).
English: A risk management plan has been submitted in line with the above.
Danish: Der er forelagt en risikohåndteringsplan i overensstemmelse med ovenstående.
English: The CHMP took these comments into account.
Danish: CHMP tog disse bemærkninger til efterretning.
English: The applicant presented literature search strategy.
Danish: Ansøgeren forelagde strategien for litteratursøgning.
English: The reference Member State (RMS) is the United Kingdom and the concerned Member States (CMS) Austria (AT), Germany (DE), Croatia (HR), Ireland (IE), Luxembourg (LU), France (FR), Belgium (BE), Netherlands (NL), Portugal (PT) and Spain (ES).
Danish: Referencemedlemsstaten (RMS) er Det Forenede Kongerige, og de berørte medlemsstater er Østrig (AT), Tyskland (DE), Kroatien (HR), Irland (IE), Luxembourg (LU), Frankrig (FR), Belgien (BE), Holland (NL), Portugal (PT) og Spanien (ES).
English: The secondary analyses showed either no difference or in favour of the combination.
Danish: De sekundære analyser viste enten ingen forskel eller var til fordel for kombinationen.
English: The following main studies were submitted by the applicant in support of the marketing authorisation application.
Danish: Følgende hovedundersøgelser blev forelagt af ansøgeren til støtte for ansøgningen om markedsføringstilladelse.
English: Ibuprofen is the safest of the NSAIDs and is therefore an optimal choice.
Danish: Ibuprofen er det sikreste NSAID og er derfor et optimalt valg.
English: The decentralised procedures UK/H/6034/001/DC, UK/H/6035/001/DC and UK/H/6176/001/DC started on 23 July 2015.
Danish: De decentrale procedurer UK/H /6034/001/DC, UK/H/6035/001/DC og UK/H/6176/001/DC blev indledt den 23. juli 2015.
English: As at the CMDh procedure no agreement could be reached the procedure was referred to the CHMP.
Danish: Da der ikke kunne opnås enighed ved CMDh-proceduren, blev proceduren indbragt for CHMP.
English: They all seem numerically similar to each other; however no formal comparison between the active substances was performed.
Danish: Numerisk synes de alle at svare til hinanden; der er imidlertid ikke foretaget en formel sammenligning mellem de aktive stoffer.
English: It is noted that there is significant use of opioid combinations in the EU.
Danish: Det bemærkes, at der er et betydeligt forbrug af kombinerede opioidpræparater i EU.
English: More importantly this is consistent with the post marketing experience of the use of the combination both world-wide and in the countries within the EU.
Danish: Vigtigere er, at dette stemmer overens med erfaringerne efter markedsføring med anvendelsen af kombinationen både på verdensbasis og i EU-landene.
English: It is worth noting that the indication being sought is for short term (3 days) exposure.
Danish: Det bør bemærkes, at den ansøgte indikation er til korttidseksponering (3 dage).
English: The use of the fixed combination will give time to both patients and physicians before an opioid containing product will be used.
Danish: Anvendelse af den faste kombination vil give både patienter og læger tid, før der anvendes et opioidholdigt produkt
English: Risk management
Danish: Risikostyring
English: For moderate pain, the benefits of the relatively small amount of ibuprofen were also not robustly shown.
Danish: For moderate smerter er fordelene ved den relativt lille mængde ibuprofen heller ikke fyldestgørende påvist.
English: In particular, the combination does not have the risks of abuse and misuse of opioids.
Danish: Navnlig medfører kombinationen ikke risiko for misbrug eller forkert brug af opioider.
English: The extensive post-marketing experience in countries outside EU indicates the potential for prolonged use is unlikely to materialise.
Danish: De omfattende erfaringer efter markedsføring i lande uden for EU tyder på, at potentialet for langvarig anvendelse næppe vil blive realiseret.
English: These risks are well known and are controlled by routine pharmacovigilance practices which CHMP has endorsed.
Danish: Disse risici er velkendte og kontrolleres gennem rutinemæssig lægemiddelovervågning, som er godkendt af CHMP.
English: • The Committee considered the notification of the referral initiated by the United Kingdom under Article 29(4) of Directive 2001/83/EC on the basis that France, Germany, Spain and The Netherlands considered that the granting of the marketing authorisation would constitute a potential serious risk to public health.
Danish: • udvalget behandlede anmeldelsen af den indbringelse, som er indledt af Det Forenede Kongerige i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF på grundlag af, at Frankrig, Tyskland, Spanien og Nederlandene fandt, at udstedelse af markedsføringstilladelsen ville udgøre en potentiel alvorlig risiko for den offentlige sundhed,
English: All the risks associated with prolonged use have been identified as safety concerns in the current risk management plan.
Danish: Alle risici ved langvarig brug er i den gældende risikostyringsplan fremhævet som sikkerhedsproblemer.
English: This is significant as there are growing concerns relating to the safety issues associated with opioids such as codeine when used in addition to paracetamol.
Danish: Dette er vigtigt, da der er stigende betænkelighed ved sikkerhedsproblemerne knyttet til opioider såsom kodein, der anvendes som tillæg til paracetamol.