natgillin/translations-raw huggingface dataset:
Ved overfølsomhed over for lægemidlet, skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen. 
If irritation occurs, seek medical advice immediately and show the package leaflet or the label to the physician.
• 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). 
• 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).
Hunden evalueres igen ca. 25 dage efter den første dosis og Na⁺/K⁺-forholdet måles. 
At approximately 25 days after the first dose, re-evaluate the dog and measure the Na⁺/K⁺ ratio.
Natriumchlorid 
Sodium chloride Chlorocresol
Nedsæt dosis til: 2,1 mg/kg kropsvægt 
Decrease dose to: 2.1 mg/kg body weight
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). 
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.
Den osmotiske gradient fremmer vandabsorption fra de renale tubuli, hvilket resulterer i øget ekstracellulær væskemængde. 
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.
Pakning med 1 hætteglas. 
Pack size of 1.
Lægemidlet bør ikke administreres af gravide og ammende kvinder. 
Pregnant and breast-feeding women should avoid administration of this product.
Depotinjektionsvæske, suspension. 
Prolonged-release suspension for injection.
SÆRLIG(E) ADVARSEL 
SPECIAL WARNING(S)
Aktivt stof: Desoxycorton pivalat 25 mg/ml 
Active substance: Desoxycortone pivalate 25 mg/ml
FARMACEUISKE OPLYSNINGER 
PHARMACEUTICAL PARTICULARS
desoxycorton pivalat 25 mg/ml 
desoxycortone pivalate 25 mg/ml
INDLÆGSSEDDEL: Zycortal 25 mg/ml depotinjektionsvæske, suspension, til hunde 
PACKAGE LEAFLET: Zycortal 25 mg/ml prolonged-release suspension for injection for dogs
2,5 mg/kg), og middel endelige doseringsinterval var 38,7 ± 12,7 dage (interval 20-99 dage). 
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.
Zycortal 25 mg/ml depotinjektionsvæske, suspension desoxycorton pivalat 
Zycortal 25 mg/ml prolonged-release suspension for injection desoxycortone pivalate
PAPKARTON 
CARDBOARD CARTON
Zycortal 25 mg/ml depotinjektionsvæske, suspension, til hunde desoxycorton pivalat 
Zycortal 25 mg/ml prolonged-release suspension for injection for dogs Desoxycortone pivalate
Zycortal 25 mg/ml depotinjektionsvæske, suspension, til hunde Desoxycorton pivalat 
Zycortal 25 mg/ml prolonged-release suspension for injection for dogs desoxycortone pivalate
Zycortal 25 mg/ml depotinjektionsvæske, suspension, til hunde 
Zycortal 25 mg/ml prolonged-release suspension for injection for dogs
25 dage efter den første dosis administreres Zycortal som følger: 
25 days after the first dose, administer Zycortal, as follows: Decrease dose to: 2.0 mg/kg body weight
Særnavn Styrke Lægemiddelform 
Invented name Strength Pharmaceutical form
Emballage Indhold 
Route of administration Packaging Content
Halvtreds af patienterne i undersøgelsen overlevede. 
Fifty of the patients in this study survived.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cyanokit den 31. november 2007. 
The European Commission granted a marketing authorisation valid throughout the European Union for Cyanokit on 31 November 2007.
Den fuldstændige EPAR for Cyanokit findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Cyanokit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den anden dosis gives over et tidsrum på mellem 15 minutter og to timer, afhængigt af patientens tilstand. 
The second dose is given over a period of between 15 minutes and two hours, depending on the patient's condition.
Oplysningerne om disse patienter blev hentet fra deres journaler, således som de var registreret i databaserne på to franske hospitaler. 
The information on these patients was obtained from their medical notes, as recorded in databases at two French hospitals.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cyanokit. 
This is a summary of the European public assessment report (EPAR) for Cyanokit.
Symptomerne på hjerneskade svandt hos 38 af 66 patienter. 
Symptoms of brain damage resolved in 38 of 66 patients.
Det gives ved en infusion af 15 minutters varighed. 
It is given as an infusion over 15 minutes.
Andre oplysninger om Cyanokit 
Other information about Cyanokit
Der er udarbejdet en risikostyringsplan for at sikre, at Cyanokit anvendes så sikkert som muligt. 
A risk management plan has been developed to ensure that Cyanokit is used as safely as possible.
Hydroxocobalamin (vitamin B12a) har været anvendt som vitamintilskud siden 1950'erne. 
Hydroxocobalamin (vitamin B12a) has been used as a vitamin supplement since the 1950s.
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 %). 
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%).
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. 
The maximum total dose is 10 g for adults, and 140 mg/kg in children up to a maximum of 10 g.
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. 
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.
Cyanokit gives som akutbehandling snarest muligt efter forgiftningen. 
Cyanokit is given as an emergency treatment as soon as possible after poisoning.
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. 
For more information about treatment with Cyanokit, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
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. 
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.
Mærkaten kan indsættes i patientjournalen, så sygehuspersonalet bliver gjort opmærksom på disse virkninger af lægemidlet. 
This can be attached to the patient's notes so that hospital staff are made aware of these effects of the medicine.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cyanokit? 
What measures are being taken to ensure the safe and effective use of Cyanokit?
Derved afbødes virkningerne af cyanidforgiftningen. 
This helps to reduce the effects of cyanide poisoning.
CHMP konkluderede, at Cyanokit synes at være en veltolereret og effektiv modgift mod cyanid, baseret på dets indvirkning på overlevelsen og forebyggelsen af hjerneskade. 
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.
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. 
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.
Det indeholder det aktive stof hydroxocobalamin (vitamin B12a). 
It contains the active substance hydroxocobalamin (vitamin B12a).
For de resterende 13 patienter blev det ikke oplyst, hvordan de reagerede. 
The response was unknown in the remaining 13 patients.
I denne undersøgelse blev patienternes tilstand på uheldsstedet sammenlignet med deres tilstand efter infusionen af Cyanokit og i de efterfølgende tre dage. 
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.
CHMP konkluderede imidlertid, at Cyanokit havde fordele frem for alternative modgifte, fordi det har en god sikkerhedsprofil hos patienter, der ikke er forgiftet. 
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.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Cyanokit, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge. 
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.
Der er ikke udført undersøgelser, der direkte sammenligner Cyanokit med andre lægemidler hos mennesker. 
There have been no studies directly comparing Cyanokit to any other treatment in humans.
Det aktive stof i Cyanokit, hydroxocobalamin, reagerer med cyanid i kroppen, hvorved der dannes cyanocobalamin, en ugiftig forbindelse, der udskilles af kroppen gennem urinen. 
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.
Hyppigheden af de øvrige bivirkninger af Cyanokit kan ikke vurderes ud fra de foreliggende oplysninger. 
The frequency of the other side effects of Cyanokit cannot be estimated with the information currently available.
To patienter overlevede, skønt de fik hjertestop, før de fik Cyanokit. 
Two patients survived despite their hearts having stopped before receiving Cyanokit.
Cyanokit gives sammen med anden passende sanerende og støttende behandling, herunder ilt til indånding. 
Cyanokit is given along with other appropriate decontamination and supportive measures, including providing oxygen for the patient to breathe.
Det kan derfor være nyttigt, når der kun er mistanke om cyanidforgiftning. 
This makes it a useful option when cyanide poisoning is only suspected.
Én undersøgelse omfattede 69 patienter med cyanidforgiftning som følge af udsættelse for røg fra ildebrande. 
In one study of 69 patients, cyanide poisoning was due to exposure to smoke from fire.
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). 
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).
Hvilken risiko er der forbundet med Cyanokit? 
What is the risk associated with Cyanokit?
Oplysningerne om virkningen af Cyanokit blev hentet fra 83 patienter, der var indlagt på mistanke om cyanidforgiftning, og som fik Cyanokit. 
Information on its effectiveness was obtained in 83 patients who had been admitted to hospital with suspected cyanide poisoning and who received Cyanokit.
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. 
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.
Derfor besluttede CHMP, at fordelene ved Cyanokit opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Cyanokit. 
Therefore, the CHMP decided that Cyanokit's benefits are greater than its risks and recommended that it be given marketing authorisation.
Dette mindsker cyanidindholdet i kroppen og standser bindingen af cyanid til enzymet cytokromoxidase, der findes i cellerne og er vigtigt for deres energiproduktion. 
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.
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. 
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.
Når en patient har fået Cyanokit, kan det gribe ind i vurderingen af eventuelle forbrændinger og i resultaterne af patientens laboratorieprøver. 
The use of Cyanokit can interfere with the assessment of burns and with laboratory test results.
Hvorfor blev Cyanokit godkendt? 
Why has Cyanokit been approved?
De fire, der døde, havde et højt cyanidindhold i blodet og fik enten hjertestop eller vejrtrækningsstop, før de fik Cyanokit. 
The four who died had high blood levels of cyanide, and either their hearts had stopped or they had stopped breathing before receiving Cyanokit.
Cyanokit er et pulver, der opløses og indgives ved infusion (dråbetilførsel) i en vene. 
Cyanokit is a powder to be made up into a solution for infusion (drip) into a vein.
Hvad er Cyanokit? 
What is Cyanokit?
Cyanokit anvendes som modgift ved kendt eller formodet cyanidforgiftning. 
Cyanokit is used as an antidote to treat known or suspected poisoning with cyanide, a highly poisonous chemical.
Den fuldstændige liste over de indberettede bivirkninger ved Cyanokit fremgår af indlægssedlen. 
For the full list of all side effects reported with Cyanokit, see the package leaflet.
Med hver pakning af Cyanokit følger en klæbemærkat, der oplyser herom. 
A sticker explaining this is supplied with every pack of Cyanokit.
Hvad anvendes Cyanokit til? 
What is Cyanokit used for?
Hvordan blev Cyanokit undersøgt? 
How has Cyanokit been studied?
Hvilken fordel viser undersøgelserne, at der er ved Cyanokit? 
What benefit has Cyanokit shown during the studies?
Der foreligger ikke oplysninger om succesraten med andre modgifte til anvendelse ved cyanidforgiftning. 
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.
Hvordan anvendes Cyanokit? 
How is Cyanokit used?
Derudover undersøgtes 14 patienter med cyanidforgiftning af anden årsag end indånding af røg. 
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.
Hvordan virker Cyanokit? 
How does Cyanokit work?
(se bilag I). 
(see Annex I).
Der er forelagt en risikohåndteringsplan i overensstemmelse med ovenstående. 
A risk management plan has been submitted in line with the above.
CHMP tog disse bemærkninger til efterretning. 
The CHMP took these comments into account.
Ansøgeren forelagde strategien for litteratursøgning. 
The applicant presented literature search strategy.
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). 
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).
De sekundære analyser viste enten ingen forskel eller var til fordel for kombinationen. 
The secondary analyses showed either no difference or in favour of the combination.
Følgende hovedundersøgelser blev forelagt af ansøgeren til støtte for ansøgningen om markedsføringstilladelse. 
The following main studies were submitted by the applicant in support of the marketing authorisation application.
Ibuprofen er det sikreste NSAID og er derfor et optimalt valg. 
Ibuprofen is the safest of the NSAIDs and is therefore an optimal choice.
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. 
The decentralised procedures UK/H/6034/001/DC, UK/H/6035/001/DC and UK/H/6176/001/DC started on 23 July 2015.
Da der ikke kunne opnås enighed ved CMDh-proceduren, blev proceduren indbragt for CHMP. 
As at the CMDh procedure no agreement could be reached the procedure was referred to the CHMP.
Numerisk synes de alle at svare til hinanden; der er imidlertid ikke foretaget en formel sammenligning mellem de aktive stoffer. 
They all seem numerically similar to each other; however no formal comparison between the active substances was performed.
Det bemærkes, at der er et betydeligt forbrug af kombinerede opioidpræparater i EU. 
It is noted that there is significant use of opioid combinations in the EU.
Vigtigere er, at dette stemmer overens med erfaringerne efter markedsføring med anvendelsen af kombinationen både på verdensbasis og i EU-landene. 
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.
Det bør bemærkes, at den ansøgte indikation er til korttidseksponering (3 dage). 
It is worth noting that the indication being sought is for short term (3 days) exposure.
Anvendelse af den faste kombination vil give både patienter og læger tid, før der anvendes et opioidholdigt produkt 
The use of the fixed combination will give time to both patients and physicians before an opioid containing product will be used.
Risikostyring 
Risk management
For moderate smerter er fordelene ved den relativt lille mængde ibuprofen heller ikke fyldestgørende påvist. 
For moderate pain, the benefits of the relatively small amount of ibuprofen were also not robustly shown.
Navnlig medfører kombinationen ikke risiko for misbrug eller forkert brug af opioider. 
In particular, the combination does not have the risks of abuse and misuse of opioids.
De omfattende erfaringer efter markedsføring i lande uden for EU tyder på, at potentialet for langvarig anvendelse næppe vil blive realiseret. 
The extensive post-marketing experience in countries outside EU indicates the potential for prolonged use is unlikely to materialise.
Disse risici er velkendte og kontrolleres gennem rutinemæssig lægemiddelovervågning, som er godkendt af CHMP. 
These risks are well known and are controlled by routine pharmacovigilance practices which CHMP has endorsed.
• 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, 
• 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.
Alle risici ved langvarig brug er i den gældende risikostyringsplan fremhævet som sikkerhedsproblemer. 
All the risks associated with prolonged use have been identified as safety concerns in the current risk management plan.
Dette er vigtigt, da der er stigende betænkelighed ved sikkerhedsproblemerne knyttet til opioider såsom kodein, der anvendes som tillæg til paracetamol. 
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.
Den 21. oktober 2016 foretog referencemedlemsstaten Det Forenede Kongerige derfor en indbringelse i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF, idet disse spørgsmål blev betragtet som en potentiel alvorlig risiko for den offentlige sundhed. 
On 21 October 2016 the RMS United Kingdom therefore triggered a referral under Article 29(4) of Directive 2001/83/EC as these issues were considered to be a potential serious risk to public health.
Ansøgeren bemærkede desuden, at PSURrapporter, der omfatter over 89 millioner tabletter anvendt på markedet, ikke har tydet på yderligere eller uventede risici. 
The applicant noted also the PSUR reports which cover over 89 million tablets of market use have not suggested any additional or unexpected risks.
Det primære mål påviste, at kombinationen var statistisk overlegen i forhold til de aktive stoffer hver for sig. 
The primary objective showed that the combination was statistically superior to the active substances individually.
For det tredje er der et medicinsk behov for en ny analgetisk fastdosiskombination uden opioidkomponent til lindring af akutte smerter. 
Thirdly, there is a medical need for a new fixed dose combination analgesic that does not contain an opioid component for relief of acute pain.
Dette potentiale er derfor så godt som uden betydning for status af lægemidlets benefit/risk-forhold. 
Therefore such a potential has virtually no impact on the benefit-risk status of the medicinal product.
Det primære endepunkt for virkningen var den tidsjusterede sum af forskellene i smerteintensitet i forhold til baseline i løbet af 48 timer. 
The primary efficacy endpoint was the time-adjusted sum of pain intensity differences from baseline over a 48 hour period.
Intermitterende manglende værdier blev estimeret ved lineær interpolation. 
Linear interpolation was use to estimate intermittent missing values.
Undersøgelsen viste, at alle de aktive stoffer var statistisk overlegne i forhold til placebo. 
In the study the active substances have all been shown to be statistically superior to placebo.
Resultaterne fra AFT-MX-6 er i overensstemmelse med AFT-MX-1, hvilket reelt yderligere styrker validiteten af resultaterne af AFT-MX-1. 
The results from AFT-MX-6 are consistent with AFT-MX-1 which in fact further reinforces the validity of the AFT-MX-1 results.
Resultaterne viste, at kombinationen medførte signifikant større smertelindring end nogen af enkeltkomponenterne (p <0,001). 
The results showed that the combination provided significantly greater pain relief than either mono-component (p<0.001).
Efter at have taget alle de af ansøgeren forelagte data i betragtning vurderede CHMP, at benefit/risk-forholdet var tilfredsstillende godtgjort. 
Having considered all the data submitted by the applicant, the CHMP considered that the benefit-risk balance was adequately demonstrated.
For det første understøttes de to aktive stoffer i denne faste kombination af omfattende publiceret og regulatorisk evidens og erfaringer, der viser deres virkning og sikkerhed. 
Firstly, the two active substances in this fixed dose combination are supported by extensive published and regulatory evidence and history of efficacy and safety.
Rationalet for kombinationsforholdet i fastdosiskombinationen 
Rationale for use of the fixed dose combination ratio