natgillin/translations-raw huggingface dataset:
• Doseringen bør svare til relevante behandlingsvejledninger. 
• Dosage should be in line with relevant treatment guidelines.
Det blev imidlertid anset for nødvendigt i mellemtiden at ajourføre produktinformationen i hele EU, så den afspejler den nuværende viden. 
However, it was considered that in the interim the product information should be updated throughout the EU to reflect what was currently known.
Det Europæiske Lægemiddelagentur har gennemgået polymyxinbaserede lægemidler 
European Medicines Agency completes review of polymyxin-based medicines
(Produkter til inhalation som tørt pulver har en anderledes dosering og fordeling i kroppen og var ikke omfattet af konklusionerne af gennemgangen). 
(Products for inhalation as a dry powder have a different dosage and distribution in the body, and were not affected by the conclusions of the review.)
Polymyxinbaserede lægemidler har været på markedet siden 1960'erne, men deres anvendelse faldt hurtigt, da der fandtes antibiotika med færre potentielle bivirkninger. 
Polymyxin-based products have been available since the 1960s, but their use quickly decreased due to the availability of antibiotics with fewer potential side effects.
1 Lægemiddelstoffets nominelle styrke = 12 500 IE/mg. 
1 Nominal potency of the drug substance = 12.500 IU/mg
Europa-Kommissionen anmodede derfor EMA om at gennemgå de foreliggende data og fremsætte anbefalinger for, hvorvidt markedsføringstilladelserne for disse lægemidler burde ændres og tilsvarende ændringer foretages i produktinformationen. 
The European Commission therefore requested the EMA to review the available data and make recommendations on whether the marketing authorisations for these medicines should be changed and the product information amended appropriately.
Colistinbase-aktivitet (CBA) (mg)1 
Colistin-base activity (CBA) (mg)1
Lægemidlet bør om muligt gives sammen med et andet velegnet antibiotikum. 
The medicine should be given with another suitable antibiotic where possible.
• Der er foretaget en gennemgang af de foreliggende oplysninger om colistimethatnatrium, og der er fremsat anbefalinger om sikker brug og passende dosering. 
• The available information on colistimethate sodium has been reviewed and recommendations have been made on its safe use and appropriate dosage.
Til kritisk syge patienter bør der anvendes en højere startdosis (støddosis) for hurtigere at opnå en effektiv koncentration af antibiotikummet. 
Critically ill patients should be given a higher starting dose (loading dose) to provide an effective level of the antibiotic in the body more quickly.
• Intravenøst colistimethatnatrium passerer ikke blod-hjernebarrieren i nævneværdigt omfang. 
• Intravenous colistimethate sodium does not cross the blood-brain barrier to a significant extent.
Gennemgangen af disse data blev foretaget af Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse. 
The review of these data was conducted by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which considered them and formulated the Agency's final opinion.
I de senere år har dette ført til en fornyet stigning i brugen af polymyxiner hos patienter, som kun har få andre behandlingsmuligheder. 
This has led to a resurgence in recent years in the use of polymyxins in patients with few other options.
• Produktoplysningerne for lægemidler indeholdende colistimethatnatrium vil blive ajourført i overensstemmelse med disse anbefalinger. 
• The product information for medicines containing colistimethate sodium will be updated as required to take these recommendations into account.
Agenturets anbefalinger bygger på en gennemgang af de foreliggende kliniske, farmakologiske og farmakokinetiske data, men der er betydelige datamangler, navnlig i farmakokinetikken hos særlige populationer såsom børn og patienter med nedsat nyrefunktion. 
The Agency's recommendations are based on a review of the available clinical, pharmacological and pharmacokinetic data, although significant gaps still exist, particularly with regard to the pharmacokinetics in special populations such as children and patients with renal impairment.
Skønt der kun forelå meget begrænsede data, fremsatte udvalget dosisanbefalinger for patienter med nyreproblemer og for børn samt vejledning om doseringen hos voksne ved direkte indgift i den væske, der omgiver hjernen eller rygmarven (intratekal eller intraventrikulær injektion). 
Although data were very limited, the Committee recommended doses for use in patients with kidney problems and in children, and provided guidance on dosage in adults when given directly into fluid surrounding the brain or spinal cord (intrathecal or intraventricular injection).
• Hos børn er den anbefalede dosis 75 000 til 150 000 IE/kg dagligt, fordelt på 3 doser. 
• In children, the suggested dose is 75,000 to 150,000 IU/kg daily, in 3 divided doses.
Den anbefalede dosis til voksne er 1-2 millioner IE dagligt fordelt på 2-3 doser, og til børn 0,5-1 millioner IE to gange dagligt, tilpasset efter sygdommens sværhed og patientens respons. 
The recommended dose in adults is 1 to 2 million IU given 2 to 3 times a day, and in children 0.5 to 1 million IU twice daily, adjusted according to the severity of the condition and the response.
Agenturet har fremsat anbefalinger for sikker anvendelse hos patienter med alvorlige infektioner, der er resistente mod sædvanlige antibiotika 
Recommendations issued for safe use in patients with serious infections resistant to standard antibiotics
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) gennemgik de foreliggende data om disse lægemidlers farmakokinetik, virkning og sikkerhed. 
The Agency's Committee for Medicinal Products for Human Use (CHMP) reviewed the available data about the pharmacokinetics, effectiveness and safety of these medicines.
Derudover er colistimethatnatrium i EU godkendt til inhalation som tørt pulver under handelsnavnet Colobreathe. 
In addition, colistimethate sodium has been approved in the EU for inhalation as a dry powder under the trade name Colobreathe.
• Doser bør altid angives i IE colistimethatnatrium. 
• Doses should always be expressed in IU of colistimethate sodium.
Udvalget anbefalede, at doserne altid angives i internationale enheder (IE), men at der indsættes en omregningstabel i produktinformationen, da dosis af colistimethatnatrium kan angives på forskellige måder. 
The Committee recommended that doses should always be expressed in international units (IU) but because doses of colistimethate sodium can be expressed in different ways a conversion table should be included in the product information.
Produkter indeholdende colistin fås til indtagelse gennem munden eller til udvendig brug, men er ikke omfattet af denne gennemgang, da de ikke menes at frembringe nævneværdige mængder af det aktive stof i kroppen. 
Products containing colistin are available for use by mouth or for external application but are not included in this review, as they are not considered to produce significant amounts of the active substance in the body.
De nuværende erfaringer peger imidlertid på, at der kan være behov for at ajourføre den eksisterende produktinformation, navnlig vedrørende doseringen og hvordan lægemidlets håndteres af kroppen (farmakokinetikken). 
However, current experience has raised concerns that the existing product information, in particular relating to dosing and the way the medicine is handled in the body (pharmacokinetics), might need updating.
Colistin og dets prodrug colistimethatnatrium er de eneste polymyxiner, der er godkendt til klinisk brug i EU, og gennemgangen blev begrænset til produkter til injektion eller inhalation (alle formuleret som colistimethatnatrium). 
Colistin and its prodrug colistimethate sodium are the only polymyxins approved for clinical use in the EU, and the review was limited to products used by injection or inhalation (all formulated as colistimethate sodium).
På grundlag af den begrænsede foreliggende evidens er den anbefalede dosis til voksne 9 millioner IE dagligt ved langsom intravenøs infusion fordelt på to eller tre doser; til kritisk syge patienter gives en støddosis på 9 millioner IE. 
Based on the limited available evidence the recommended dose in adults is 9 million IU daily in 2 or 3 divided doses as a slow intravenous infusion; in critically ill patients a loading dose of 9 million IU should be given.
Koadministration med et andet antibiotikum bør altid overvejes, når det er muligt. 
Consideration should be given to co-administration with another antibacterial agent whenever this is possible.
Delvis som følge af den begrænsede brug har colistimethatnatrium bevaret sin virkning mod en række bakterier, der er blevet resistente over for sædvanlige antibiotika. 
Due in part to this limited use, colistimethate sodium has retained activity against a number of bacteria which have become resistant to commonly used antibiotics.
Når det er hensigtsmæssigt, anbefales til voksne en dosis på 125 000 IE intraventrikulært og højst denne dosis intratekalt. 
Where appropriate, adult doses of 125,000 IU for intraventricular administration and no more than this for intrathecal administration are recommended.
I henhold til artikel 5, stk. 3, i forordning (EF) nr. 726/2004 foregår der en sideløbende gennemgang, der ser nærmere på præparaternes kvalitet og den anvendte metode til måling og testning af colistimethatnatriums styrke. 
A parallel review under Article 5(3) of Regulation (EC) No 726/2004 is currently also under way, looking at the quality of the products and the way the potency of colistimethate sodium is measured and tested, and may result in further changes to the product information once complete.
Colistimethatnatrium gives ved injektion eller inhalation og omdannes i kroppen til colistin. 
Colistimethate sodium is given by injection or inhaled, and becomes colistin inside the body.
Colistimethatnatrium (mg) 
Colistimethate sodium (mg)
Hos patienter med nyrefunktionsnedsættelse bør dosis nedsættes i henhold til kreatininclearance. 
Doses should be reduced according to creatinine clearance in patients with renal impairment.
Colistimethatnatrium (IE) 
Colistimethate sodium (IU)
Gennemgangen omfattede produkter, der gives ved injektion eller inhalation i væskeform (systemisk anvendelse), og som indeholder colistimethatnatrium, der i kroppen omdannes til det aktive stof colistin. 
The review considered products given by injection or inhaled as a liquid into the lungs (systemic use) containing colistimethate sodium, which is converted to the active substance colistin in the body.
• Injektion eller infusion (drop) af colistimethatnatrium bør kun anvendes ved alvorlige infektioner, hvor der er få andre behandlingsmuligheder, og normalt i kombination med et andet antibiotikum. 
• Injection or infusion (drip) of colistimethate sodium should only be used to treat serious infections in patients with few other treatment options, normally combined with another antibiotic.
I produktinformationen indsættes følgende tabel for at imødegå forskellene i styrkeangivelse for colistimethatnatrium og colistin mellem EU og andre regioner såsom USA og Australien, da dette har givet anledning til ukorrekte angivelser i den medicinske litteratur og kan tænkes at medføre alvorlige medicineringsfejl: 
To address the differences in the way in which the strength of colistimethate sodium and colistin are expressed in the EU and in other regions such as the USA and Australia, which has led to errors in reporting in the medical literature and could potentially lead to serious medication errors, the following table will be included in the product information:
• Colistin og colistimethatnatrium er ældre antibiotika i klassen polymyxiner, der undertiden bruges mod infektioner, som er resistente mod nyere lægemidler. 
• Colistin and colistimethate sodium are older antibiotics (belonging to the class called polymyxins) that are sometimes used for infections that have become resistant to newer treatments.
• Intravenøst colistimethatnatrium er indiceret hos voksne og børn, herunder nyfødte, til behandling af alvorlige infektioner forårsaget af aerobe gramnegative patogener hos patienter med få andre behandlingsmuligheder. 
• Intravenous colistimethate sodium is indicated in adults and children including neonates for the treatment of serious infections due to aerobic Gram-negative pathogens in patients with limited treatment options.
CHMP konkluderede, at colistimethatnatrium ved cystisk fibrose også kan gives ved inhalation eller med nebulisator til patienter med vedvarende (kroniske) infektioner med bakterien Pseudomonas aeruginosa. 
CHMP concluded that colistimethate sodium may also be given by inhalation or in a nebuliser to treat ongoing (chronic) infections with the bacterium Pseudomonas aeruginosa in patients with cystic fibrosis.
Den 23. oktober 2014 afsluttede Det Europæiske Lægemiddelagentur (EMA) en gennemgang af sikkerheden og virkningen af lægemidler, der indeholder antibiotikaene colistin eller colistimethatnatrium (også kaldet polymyxiner). 
On 23 October 2014 the European Medicines Agency (EMA) completed a review of the safety and effectiveness of products containing the antibiotics colistin or colistimethate sodium (known as polymyxins) and recommended changes to their product information to ensure safe use in the treatment of serious infections that are resistant to standard antibiotics.
CHMP konkluderede, at colistimethatnatrium til injektion eller infusion (drop) bør være forbeholdt alvorlige infektioner med følsomme bakterier hos patienter med få andre behandlingsmuligheder. 
The CHMP concluded that injection or infusion (drip) of colistimethate sodium should be reserved for the treatment of serious infections due to susceptible bacteria, in patients whose other treatment options are limited.
• Der bør udvises stor forsigtighed ved intravenøs indgift af colistimethatnatrium sammen med andre potentielt nefrotoksiske eller neurotoksiske lægemidler. 
• Use of intravenous colistimethate sodium together with other medications that are potentially nephrotoxic or neurotoxic should be undertaken with great caution.
Den igangværende forskning kan tænkes at tilføre yderligere viden om farmakodynamikken og farmakokinetikken af disse lægemidler. 
Research currently underway may provide further information on pharmacodynamics and pharmacokinetics of these medicines to improve the evidence-base behind any dose recommendations.
Sideløbende pågår en gennemgang, der ser nærmere på præparaternes kvalitet og den anvendte metode til måling og testning af colistimethatnatriums styrke. 
A parallel review is currently underway, looking at the quality of the products and the way the potency of colistimethate sodium is measured and tested, and may result in further changes to the product information once complete.
Polymyxiner er en gruppe antibiotika, der dels omfatter colistin, dels colistimethatnatrium, som er et lægemiddelforstadium (“prodrug”), der i kroppen omdannes til colistin. 
Polymyxins are a group of antibiotics that includes colistin and colistimethate sodium (a ‘prodrug' that is converted to colistin in the body), which have been available in the EU since the 1960s for the treatment of susceptible infections.
Gennemgangen omfattede ikke præparater til indtagelse gennem munden (disse indeholder hovedsagelig colistin og optages ikke i nævneværdige mængder i kroppen, men virker lokalt i tarmen). 
Products taken by mouth (which mainly contain colistin and are not absorbed into the body in significant amounts but act locally on the gut) and those applied externally were not covered in this review.
• Ved cystisk fibrose hos voksne og børn kan colistimethatnatrium gives ved inhalation til behandling af kroniske lungeinfektioner med Pseudomonas aeruginosa. 
• When given by inhalation, colistimethate sodium solutions may be used for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adults and children with cystic fibrosis.
Hos patienter med cystisk fibrose kan colistimethatnatrium desuden anvendes som inhalationsdamp til behandling af lungeinfektioner. 
Colistimethate sodium may also be inhaled as a liquid vapour to treat lung infection in patients with cystic fibrosis.
Markedsføringstilladelsen var baseret på den tilladelse, som blev udstedt for Renvela i 2009 ("informeret samtykke"). 
This authorisation was based on the authorisation granted to Renvela in 2009 (‘informed consent').
• voksne og børn fra 6 år og opefter med kronisk (langvarig) nyresygdom. 
• adults and children from 6 years of age with chronic (long-term) kidney disease.
• voksne patienter i dialyse (en teknik, hvor man fjerner uønskede stoffer fra blodet) 
• adult patients on dialysis (a technique to remove unwanted substances from the blood);
Sevelamer carbonate Winthrop fik en markedsføringstilladelse med gyldighed i hele EU den 15. januar 2015. 
Sevelamer carbonate Winthrop received a marketing authorisation valid throughout the EU on 15 January 2015.
Yderligere information om Sevelamer carbonate Winthrop findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/sevelamer-carbonate-winthrop. 
Further information on Sevelamer carbonate Winthrop can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/sevelamer-carbonate-winthrop.
Dosen afhænger af patientens niveau af fosfat i blodet og for børns vedkommende af højde og vægt. 
The dose to take depends on the patient's level of blood phosphate and, for children, their height and weight.
Sevelamer carbonate Winthrop fås som tabletter (800 mg) og som pulver (800 mg og 2,4 g), som skal tages tre gange om dagen sammen med et måltid. 
Sevelamer carbonate Winthrop is available as tablets (800 mg) and as powder (800 mg and 2.4 g) to be taken 3 times a day with meals.
1 Tidligere kendt som Sevelamer carbonate Zentiva. 
1 Previously known as Sevelamer carbonate Zentiva.
De hyppigste bivirkninger ved Sevelamer carbonate Winthrop (som kan forekomme hos mere end 1 ud af 10 personer) er kvalme, opkastning, smerter i den øvre del af maven og forstoppelse. 
The most common side effects with Sevelamer carbonate Winthrop (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, upper abdominal (belly) pain and constipation.
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Sevelamer carbonate Winthrop opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
The European Medicines Agency therefore decided that Sevelamer carbonate Winthrop's benefits are greater than its risks and it can be authorised for use in the EU.
Når lægemidlet tages med et måltid, binder det sig i tarmen til fosfat fra maden og forhindrer dermed fosfatet i at blive optaget i kroppen, hvilket reducerer fosfatniveauet i blodet. 
When taken with meals, it attaches in the gut to phosphate from the food, thereby preventing the phosphate from being absorbed into the body and helping to reduce phosphate levels in the blood.
Som for alle lægemidler bliver data vedrørende brugen af Sevelamer carbonate Winthrop løbende overvåget. 
As for all medicines, data on the use of Sevelamer carbonate Winthrop are continuously monitored.
I et tredje hovedstudie hos 49 voksne, som ikke var i dialyse, medførte Sevelamer carbonate Winthrop et fald i fosfatniveauet fra 2,0 mmol/l til 1,6 mmol/l. 
In a third main study in 49 adults who were not on dialysis, Sevelamer carbonate Winthrop reduced phosphate levels from 2.0 mmol/l to 1.6 mmol/l.
Hvis du ønsker mere information om anvendelsen af Sevelamer carbonate Winthrop, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet. 
For more information about using Sevelamer carbonate Winthrop, see the package leaflet or contact your doctor or pharmacist.
I to hovedstudier hos 110 voksne med nyresygdom, som var i dialyse, medførte Sevelamer carbonate Winthrop et fald i fosfatniveauet til ca. 1,5-1,6 mmol/l (hvilket er inden for eller tæt på normalområdet), og det var lige så effektivt som et andet godkendt lægemiddel, Renagel. 
In two main studies in 110 adults with kidney disease who were on dialysis, Sevelamer carbonate Winthrop brought phosphate levels down to around 1.5-1.6 mmol/l (which is within or close to the normal range) and was as effective as another approved medicine Renagel.
Sevelamer carbonate Winthrop må ikke tages på tom mave, og patienterne bør overholde den ordinerede kostplan. 
Sevelamer carbonate Winthrop must not be taken on an empty stomach and patients should keep to their prescribed diets.
De indberettede bivirkninger ved Sevelamer carbonate Winthrop vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Sevelamer carbonate Winthrop are carefully evaluated and any necessary action taken to protect patients.
Det indeholder det aktive stof sevelamercarbonat. 
It contains the active substance sevelamer carbonate.
Sevelamer carbonate Winthrop bør anvendes sammen med andre behandlinger, som f.eks. tilskud af calcium og D-vitamin, for at forebygge knoglesygdom. 
Sevelamer carbonate Winthrop should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.
Det aktive stof i Sevelamer carbonate Winthrop, sevelamercarbonat, er en fosfatbinder. 
The active substance in Sevelamer carbonate Winthrop, sevelamer carbonate, is a phosphate binder.
En oversigt over Sevelamer carbonate Winthrop, og hvorfor det er godkendt i EU 
An overview of Sevelamer carbonate Winthrop and why it is authorised in the EU
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Sevelamer carbonate Winthrop? 
What measures are being taken to ensure the safe and effective use of Sevelamer carbonate Winthrop?
(sevelamercarbonat) 
(sevelamer carbonate)
Sevelamer carbonate Winthrop er et lægemiddel, der anvendes til regulering af hyperfosfatæmi (forhøjet niveau af fosfat i blodet) hos: 
Sevelamer carbonate Winthrop is a medicine used to control hyperphosphataemia (high blood phosphate levels) in:
Sevelamer carbonate Winthrop må ikke anvendes hos personer med lavt fosfatindhold i blodet eller tarmobstruktion (en blokering af tarmen). 
Sevelamer carbonate Winthrop must not be used in people with low blood phosphate levels or with bowel obstruction (a blockage in the gut).
Studier har vist, at Sevelamer carbonate Winthrop er effektivt til at sænke niveauet af fosfat i blodet hos patienter med hyperfosfatæmi, og bivirkningerne anses for håndterbare. 
Studies show that Sevelamer carbonate Winthrop is effective at reducing levels of blood phosphate in patients with hyperphosphataemia, and its side effects are considered manageable.
Hvad er Sevelamer carbonate Winthrop, og hvad anvendes det til? 
What is Sevelamer carbonate Winthrop and what is it used for?
Hos børn, der fik Sevelamer carbonate Winthrop, sås et større fald i fosfor (0,87 mg/dl) end hos børn, der fik placebo (en uvirksom behandling), hvor der sås en stigning i fosfor på 0,04 mg/dl. 
Finally, a main study also showed that Sevelamer carbonate Winthrop was effective at lowering phosphate levels in 100 children: children who took Sevelamer carbonate Winthrop had a greater reduction in phosphorous (0.87 mg/dl) than those taking placebo (a dummy treatment) who had a rise in phosphorous of 0.04 mg/dl.
Andre oplysninger om Sevelamer carbonate Winthrop 
Other information about Sevelamer carbonate Winthrop
Hvorfor blev Sevelamer carbonate Winthrop godkendt? 
Why is Sevelamer carbonate Winthrop approved?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Sevelamer carbonate Winthrop. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sevelamer carbonate Winthrop have been included in the summary of product characteristics and the package leaflet.
Hvilke risici er der forbundet med Sevelamer carbonate Winthrop? 
What are the risks associated with Sevelamer carbonate Winthrop?