natgillin/translations-raw huggingface dataset:
Escherichia Coli (inaktiveret) 200 megaceller / Ml, Klebsiella Pneumoniae (inaktiveret) 100 megaceller / Ml, Staphylococcus Aureus Inaktiverede Bakterier 500 megaceller / Ml, Staphylococcus Epidermidis inaktiverede bakterier 500 megaceller / Ml Streptococcus Salivarius inaktiverede bakterier 100 megaceller / Ml, Streptococcus Pneumoniae inaktiverede bakterier 100 megaceller / Ml, Streptococcus Pyogenes inaktiverede bakterier 100 megaceller / Ml, Haemophilus Influenzae inaktiverede bakterier 100 megaceller / Ml, Corynebacterium Pseudodiphtheriticum inaktiverede bakterier 200 megaceller / Ml, Moraxella Catarrhalis inaktiverede bakterier 100 megaceller / MI 
Escherichia Coli (Inactivated) 200 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 100 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 500 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 500 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 100 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 100 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 100 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 100 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 200 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 100 Mega Cells / Ml
Standardiseret Lyophylisat af bakterielle lysater 7 mg kapsel 
Standardized Lyophylisate Of Bacterial Lysates 7mg Capsule
Frysetørret (lyofiliseret), standardiseret bakteriel lysat 3,5 mg kapsel 
Freeze-Dried (Lyophilised), Standardised Bacterial Lysate 3.5mg Capsule
Standardiseret Lyophylisat af bakterielle lysater 3,5 mg kapsel 
Standardized Lyophylisate Of Bacterial Lysates 3.5mg Capsule
Lyofiliserede bakterielle lysater 7 mg kapsel 
Lyophilized Bacterial Lysates 7mg Capsule
Broncho-Vaxom Lyofiliseret, standardiseret bakterieekstrakt 3,5 mg kapsel 
Broncho-Vaxom Lyophilised, Standardised Bacterial Extract 3.5mg Capsule
Broncho-Vaxom Lyofiliserede bakterielle lysater 3,5 mg kapsel 
Broncho-Vaxom Lyophilized Bacterial Lysates 3.5mg Capsule
Lyofiliseret, standardiseret bakterieekstrakt 7 mg kapsel 
Lyophilised, Standardised Bacterial Extract 7mg Capsule
Lyofiliserede bakterielle lysater 3,5 mg kapsel 
Lyophilized Bacterial Lysates 3.5mg Capsule
Broncho Vaxom Lyofiliserede bakterielle lysater 7 mg kapsel 
Broncho Vaxom Lyophilized Bacterial Lysates 7mg Capsule
Membraner Fraktioner af Klebsiella Pneumoniae 15 enheder / Ml, Ribosomer af Haemophilus Influenzae 0,5 enheder / Ml, Ribosomer af Streptococcus Pneumoniae 3 enheder / Ml, Ribosomale Fraktioner af Klebsiella Pneumoniae 3,5 enheder / Ml, Ribosomer fra Streptococcus Pyogenes Gruppe A 3 enheder / Ml 
Membranes Fractions Of Klebsiella Pneumoniae 15 Units / Ml, Ribosomes Of Haemophilus Influenzae 0.5 Units / Ml, Ribosomes Of Streptococcus Pneumoniae 3 Units / Ml, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units / Ml, Ribosomes From Streptococcus Pyogenes Group A 3 Units / Ml
Glycine 43 mg tablet, Haemophilus Influenzae Type B (Hib) 6 giga organismer tablet, Klebsiella Ozaenae 6 giga organismer tablet, Klebsiella Pneumoniae 6 giga organismer tablet, Neisseria Catarrhalis 6 giga organismer tablet, Staphylococcus Aureus 6 giga organismer tablet, Streptococcus Pneumoniae 6 giga organismer tablet, Streptococcus Pyogenes 6 giga organismer tablet, Streptococcus Viridans 6 giga organismer tablet, Lyofiliserede Bakterielle Lysater 50 mg tablet 
Glycine 43mg Tablet, Haemophilus Influenzae Type B (Hib) 6 Giga Organisms Tablet, Klebsiella Ozaenae 6 Giga Organisms Tablet, Klebsiella Pneumoniae 6 Giga Organisms Tablet, Neisseria Catarrhalis 6 Giga Organisms Tablet, Staphylococcus Aureus 6 Giga Organisms Tablet, Streptococcus Pneumoniae 6 Giga Organisms Tablet, Streptococcus Pyogenes 6 Giga Organisms Tablet, Streptococcus Viridans 6 Giga Organisms Tablet, Lyophilized Bacterial Lysates 50mg Tablet
Glycine 43 mg tablet, Haemophilus Influenzae Type B (Hib) 6 giga organismer tablet, Klebsiella Ozaenae 6 giga organismer tablet, Klebsiella Pneumoniae 6 giga organismer tablet, Neisseria Catarrhalis 6 giga organismer tablet, Staphylococcus Aureus 6 giga organismer tablet, Streptococcus Pneumoniae 6 giga organismer tablet , Streptococcus Pyogenes 6 giga organismer tablet, Streptococcus Oralis 6 giga organismer tablet, Lyofiliserede Bakterielle Lysater 50 mg tablet 
Glycine 43mg Tablet, Haemophilus Influenzae Type B (Hib) 6 Giga Organisms Tablet, Klebsiella Ozaenae 6 Giga Organisms Tablet, Klebsiella Pneumoniae 6 Giga Organisms Tablet, Neisseria Catarrhalis 6 Giga Organisms Tablet, Staphylococcus Aureus 6 Giga Organisms Tablet, Streptococcus Pneumoniae 6 Giga Organisms Tablet, Streptococcus Pyogenes 6 Giga Organisms Tablet, Streptococcus Oralis 6 Giga Organisms Tablet, Lyophilized Bacterial Lysates 50mg Tablet
Lyofiliseret, standardiseret bakterieekstrakt 3,5 mg kapsel 
Lyophilised, Standardised Bacterial Extract 3.5mg Capsule
Proteoglycaner af Klebsiella Pneumoniae 1,125 mg pose, Ribosomer af Haemophilus Influenzae 5 enheder pose, Ribosomer af Streptococcus Pneumoniae 30 enheder pose, Ribosomale Fraktioner af Klebsiella Pneumoniae 35 enheder pose, Ribosomer fra Streptococcus Pyogenes Gruppe A 30 enheder pose 
Proteoglycanes Of Klebsiella Pneumoniae 1.125mg Sachet, Ribosomes Of Haemophilus Influenzae 5 Units Sachet, Ribosomes Of Streptococcus Pneumoniae 30 Units Sachet, Ribosomal Fractions Of Klebsiella Pneumoniae 35 Units Sachet, Ribosomes From Streptococcus Pyogenes Group A 30 Units Sachet
Broncho-Vaxom Lyofiliserede bakterielle lysater 3,5 mg pose 
Broncho-Vaxom Lyophilized Bacterial Lysates 3.5mg Sachet
Broncho-Vaxom Lyofiliserede bakterielle lysater 7 mg kapsel 
Broncho-Vaxom Lyophilized Bacterial Lysates 7mg Capsule
Haemophilus Influenzae 6 giga celler tablet, Klebsiella Ozaenae 6 giga celler tablet, Klebsiella Pneumoniae 6 giga celler tablet, Neisseria Catarrhalis 6 giga celler tablet, Staphylococcus Aureus 6 giga celler tablet, Streptococcus Pneumoniae 6 giga celler tablet, Streptococcus Pyogenes 6 giga celler tablet, Streptococcus Oralis 6 giga celler tablet 
Haemophilus Influenzae 6 Giga Cells Tablet, Klebsiella Ozaenae 6 Giga Cells Tablet, Klebsiella Pneumoniae 6 GigaCells Tablet, Neisseria Catarrhalis 6 Giga Cells Tablet, Staphylococcus Aureus 6 Giga Cells Tablet, Streptococcus Pneumoniae 6 Giga Cells Tablet, Streptococcus Pyogenes 6 Giga Cells Tablet, Streptococcus Oralis 6GigaCells Tablet
Haemophilus Influenzae 6 gigaceller tablet, Klebsiella Ozaenae 6 gigaceller tablet, Klebsiella Pneumoniae 6 gigaceller tablet, Neisseria Catarrhalis 6 gigaceller tablet, Staphylococcus Aureus 6 gigaceller tablet, Streptococcus Pneumoniae 6 gigaceller tablet, Streptococcus Pyogenes 6 gigaceller tablet, Streptococcus Viridans 6 gigaceller tablet 
Haemophilus Influenzae 6 Giga Cells Tablet, Klebsiella Ozaenae 6 Giga Cells Tablet, Klebsiella Pneumoniae 6 Giga Cells Tablet, Neisseria Catarrhalis 6 Giga Cells Tablet, Staphylococcus Aureus 6 Giga Cells Tablet, Streptococcus Pneumoniae 6 Giga Cells Tablet, Streptococcus Pyogenes 6 Giga Cells Tablet, Streptococcus Viridans 6 Giga Cells Tablet
Membraner Fraktioner af Klebsiella Pneumoniae 15 enheder tablet, Ribosomer af Haemophilus Influenzae 0,5 enheder tablet, Ribosomer af Streptococcus Pneumoniae 3 enheder tablet, Ribosomale Fraktioner af Klebsiella Pneumoniae 3,5 enheder tablet, Ribosomer fra Streptococcus Pyogenes Gruppe A 3 enheder tablet 
Membranes Fractions Of Klebsiella Pneumoniae 15 Units Tablet, Ribosomes Of Haemophilus Influenzae 0.5 Units Tablet, Ribosomes Of Streptococcus Pneumoniae 3 Units Tablet, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Tablet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Tablet
Membraner Fraktioner af Klebsiella Pneumoniae 15 enheder, Ribosomer af Haemophilus Influenzae 0,5 enheder, Ribosomer af Streptococcus Pneumoniae 3 enheder, Ribosomale Fraktioner af Klebsiella Pneumoniae 3,5 enheder, Ribosomer fra Streptococcus Pyogenes Gruppe A 3 enheder 
Membranes Fractions Of Klebsiella Pneumoniae 15 Units, Ribosomes Of Haemophilus Influenzae 0.5 Units, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units, Ribosomes From Streptococcus Pyogenes Group A 3 Units
Lyofiliserede bakterielle lysater 3,5 mg pose 
Lyophilized Bacterial Lysates 3.5mg Sachet
Lysatum Bakteriale Mixtum 3,5 mg pose 
Lysatum Bacteriale Mixtum 3.5mg Sachet
3 inhaltorer (3 x 30 doser (multipakning) 
3 inhalers (3 x 30 doses) (multipack)
Lægemiddelform Administration Emballage Pakningsstørrelse 
Strength Pharmaceutical Form Route of Administration
(Særnavn) navn Styrke 
MA (EU) number (Invented) name
Til inhallation 
Immediate Packaging
EMA´s procedurenr. 
Pack size
18. juni 2012 
18 June 2012
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 18. juni 2012. 
The final opinion was converted into a Decision by the European Commission on 18 June 2012.
Udvalget udpegede dr.Michael Holzhauser-Alberti som rapportør og dr. David Murphy som co-rapportør. 
The Committee appointed Dr Michael Holzhauser-Alberti as rapporteur and Dr David Murphy as co-rapporteur.
Artikel 34 i direktiv 2001/82/EF, med senere ændringer. 
Article 34 of Directive 2001/82/EC, as amended
Indbringelsesproceduren blev indledt den 14. september 2011. 
The referral procedure started on 14 September 2011.
Disse veterinærlægemidler er til behandling af forskellige parasitinfektioner hos hunde, som er forårsaget af nematoder og cestoder. 
These veterinary medicinal products are intended for the treatment of various parasitic infections in dogs caused by nematodes and cestodes.
Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 2. december 2011. 
Written explanations were provided by the marketing authorisation holder on 2 December 2011.
Febantel er et probenzimidazol. 
Febantel is a probenzimidazole.
Internationalt fællesnavn (INN): Praziquantel, pyrantel og febantel 
International non-proprietary name (inn): Praziquantel, pyrantel and febantel
Listen over de pågældende lægemiddelnavne fremgår af bilag I. De videnskabelige konklusioner findes i bilag II, og det ændrede produktresumé, etikettering og indlægsseddel findes i bilag III. 
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended summary of product characteristics, package leaflet and labelling in the Annex III.
Praziquantel er et delvist hydrogeneret pyrazinoisoquinolin-derivat. 
Praziquantel is a partially hydrogenated pyrazinoisoquinoline derivative.
Pyrantel embonat (pamoat) er et tetrahydropyrimidin-derivat. 
Pyrantel embonate (pamoate) is a tetrahydropyrimidine derivative.
På grund af de divergerende nationale afgørelser, der er truffet af medlemsstaterne med hensyn til indikationerne for og anvendelsen af disse lægemidler til hundehvalpe på under 9 uger og hunde, der vejer under 2,5 kg, i forbindelse med markedsføringstilladelserne for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus og tilknyttede navne, indbragte Frankrig den 22. juli 2011 sagen for CVMP i henhold til artikel 34, stk. 1, i direktiv 2001/82/EF, for at få løst de ovennævnte divergenser. 
Due to the divergent national decisions taken by Member States regarding the indications and use in pups less than 9 weeks of age and dogs weighing less than 2.5 kg concerning the authorisations of Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names, on 22 July 2011 France referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve the above mentioned divergences.
På baggrund af vurderingen af de aktuelt foreliggende data var CVMP af den opfattelse, at den overordnede benefit/risk-profil for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus og tilknyttede navne (godkendt ved gensidig anerkendelsesprocedure nr. IE/V/0272-0275/001/MR) fortsat er positiv, forudsat at markedsføringstilladelserne ændres i overensstemmelse med de anbefalede ændringer til 
Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus and associated names (authorised via Mutual Recognition Procedure No IE/V/0272-0275/001/MR) remains positive subject to variation of the marketing authorisations in accordance with the recommended changes to the product information.
Udtalelse som følge af en sag indbragt i henhold til artikel 34F F for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus og Prazitel Plus og tilknyttede navne EMA/480398/2012 
Opinion following an Article 34F F referral for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names EMA/289985/2012
De fås som tabletter indeholdende 50 mg praziquantel, 50 mg pyrantel (svarende til 144 mg pyrantel embonat) og 150 mg febantel. 
Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus (and associated names) are veterinary medicinal products as tablets for dogs containing 50 mg praziquantel, 50 mg pyrantel (equivalent to 144 mg pyrantel embonate) and 150 mg of febantel.
CVMP vedtog derfor en positiv udtalelse den 7. marts 2012, hvori det anbefalede ændring af betingelserne i markedsføringstilladelserne for Milaxyn Plus, Strantel Plus, Prazical Plus og Voxical Plus (og tilknyttede navne) (godkendt ved gensidig anerkendelsesprocedure nr. IE/V/0272-0275/001/MR) og opretholdelse af markedsføringstilladelserne for Prazitel Plus, Exitel Plus og Cazitel Plus (og tilknyttede navne) (godkendt ved gensidig anerkendelsesprocedure nr. IE/V/02410243/001/MR). 
terms of the marketing authorisations for Milaxyn Plus, Strantel Plus, Prazical Plus and Voxical Plus (and associated names) (authorised via Mutual Recognition Procedure No IE/V/0272-0275/001/MR) and the maintenance of the marketing authorisations for Prazitel Plus, Exitel Plus and Cazitel Plus (and associated names) (authorised via Mutual Recognition Procedure No IE/V/0241-0243/001/MR).
Udtalelse som følge af en sag indbragt i henhold til artikel for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus og Prazitel Plus og tilknyttede navne 
Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names
• Det anvendes til børn og unge i alderen 6-17 år. 
• it is used in children and adolescents aged 6-17 years.
pædagogiske og sociale tiltag. 
educational and social measures.
• Det bør anvendes som en del af et behandlingsprogram, der typisk omfatter psykologiske, 
• It should be used as part of a treatment programme which typically includes psychological,
• Det anvendes kun, når et andet lægemiddel, der kaldes methylphenidat, har vist sig ikke at være tilstrækkeligt effektivt. 
• it is used only after when another medicine called methylphenidate was not sufficiently effective.
Diagnosen bør stilles i henhold til DSM-5-kriterier eller retningslinjerne i ICD-10 og bør baseres på en omfattende multidisciplinær evaluering af patienten. 
Diagnosis should be made according to DSM-5 criteria or the guidelines in ICD-10 and should be based on a comprehensive multidisciplinary evaluation of the patient.
Indlægsseddel: Information til patienten {Dexamed} 5 mg tabletter 
Package leaflet: Information for the patient Dexamed 5 mg tablets
Et omfattende behandlingsprogram inkluderer typisk psykologiske, pædagogiske og sociale tiltag. 
A comprehensive treatment programme typically includes psychological, educational and social measures.
Dexamfetamin har et stort potentiale for at føre til afhængighed, og det er ofte blevet/bliver ofte misbrugt. 
Dexamfetamine possesses a high potential to cause dependency and has been/is frequently abused.
4.1 Terapeutiske indikationer [Ordlyden i dette punkt skal være følgende] 
4.1 Therapeutic indications [The wording of this section should read as follows]
Behandlingen bør foretages under supervision af en specialist i adfærdssygdomme hos børn og/eller unge. 
Treatment should be under the supervision of a specialist in childhood and/or adolescent behavioural disorders.
Dexamfetamin er indiceret som en del af et omfattende behandlingsprogram for attention deficit and hyperactivity disorder (ADHD) hos børn og unge i alderen 6 til 17 år, når responset på tidligere behandling med methylphenidat anses for at være klinisk utilstrækkeligt. 
Dexamfetamine is indicated as part of a comprehensive treatment programme for attentiondeficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years when response to previous methylphenidate treatment is considered clinically inadequate.
Dexamfetamin er ikke indiceret til alle børn med ADHD, og beslutningen om at anvende dexamfetamin skal baseres på en meget grundig vurdering af, hvor svære og kroniske barnets symptomer er i forhold til barnets alder, samt muligheden for misbrug, forkert brug eller videresalg. 
Dexamfetamine is not indicated in all children with ADHD and the decision to use dexamfetamine must be based on a very thorough assessment of the severity and chronicity of the child's symptoms in relation to the child's age and potential for abuse, misuse or diversion.
Misbrug, forkert brug og videresalg 
Abuse, misuse, and diversion
[Ordlyden nedenfor skal slettes] 
[The wording below should be deleted]
[Den følgende ordlyd skal tilføjes i slutningen af dette punkt] Indberetning af formodede bivirkninger 
[The following wording should be added at the end of this section] Reporting of suspected adverse reactions
[Følgende ordlyd skal indsættes øverst i dokumentet] 
[The below wording should be inserted at the top of the document]
Ændringer til produktresuméet og indlægssedlen 
Amendments to the summary of product characteristics and package leaflet
[Følgende ordlyd skal tilføjes i slutningen af dette punkt] 
[The following wording should be added at the end of this section]
Anvendelse [Disse punkter skal have følgende ordlyd] {Dexamed} anvendes til at behandle ADHD (attention deficit and hyperactivity disorder). 
Dexamed is used to treat attention-deficit/hyperactivity disorder (ADHD).
• Det er ikke alle børn med ADHD, der skal have {Dexamed og relaterede navne}. 
• it is not indicated in all children with ADHD.
Risikoen er generelt større for stimulanter med kort virkningsvarighed end for tilsvarende præparater med lang virkningsvarighed (se pkt. 
[The following sentence should be added in its place] The risk is generally greater for short acting stimulants than for corresponding long-acting products (see section 4.1).
Bemærk: Disse ændringer skal indføres i det gældende produktresumé, etikettering og indlægsseddel. 
Note: These amendments are to be incorporated to the valid Summary of Product Characteristics, labelling and package leaflet which are the final versions achieved during the Coordination group procedure
(Særnavn) Navn 
(Invented) name Strength Pharmaceutical Form
Dette sammendrag blev sidst ajourført i 09-2007 
This summary was last updated in 09-2007.
Markedsføringstilladelsen blev fornyet den 21. marts 2007. 
The marketing authorisation was renewed on 21 March 2007.
Dosis kan tilpasses afhængigt af kropsvægten. 
The dose may be adjusted, depending on body weight.
Indehaveren af markedsføringstilladelsen er Glaxo Group Ltd. 
The marketing authorisation holder is Glaxo Group Ltd.
Behandlingen bør indledes hurtigst muligt, efter at diagnosen er stillet og bør fortsætte i op til otte dage, eller indtil patienten udskrives fra hospitalet. 
Treatment should be started as soon as possible after diagnosis and continued for up to eight days or until the patient is discharged from hospital.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Quixidar den 21. marts 2002. 
The European Commission granted a marketing authorisation valid throughout the European Union for Quixidar on 21 March 2002.
Til operationspatienter skal den første dosis gives 6 timer efter afslutning af operationen. 
For patients having surgery, the first dose should be given six hours after the end of the operation.
Andre oplysninger om Quixidar: 
Other information about Quixidar:
I alle undersøgelserne var hovedmålet for effekt den samlede hyppighed af trombotiske komplikationer (problemer forårsaget af blodpropper). 
In all studies, the main measure of effectiveness was the overall rate of thrombotic events (problems caused by blood clots).
Den fuldstændige EPAR for Quixidar findes her. 
The full EPAR for Quixidar can be found here.
Disse resultater var dog ikke tilstrækkelige til at vise, hvorvidt Quixidar var mere effektiv end ufraktioneret heparin. 
However, these results were insufficient to show whether Quixidar was more effective than unfractionated heparin or not.
Som for andre antitrombotiske lægemidler er den hyppigste bivirkning af Quixidar blødning. 
As with other antithrombotic medicines, the most common side effect of Quixidar is bleeding.
EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) QUIXIDAR EPAR - sammendrag for offentligheden 
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) QUIXIDAR EPAR summary for the public
Hovedmålestokken for effekt var andelen af patienter, som døde eller var ude for en ‘iskæmisk hændelse' (begrænsning af blodforsyningen til et organ, herunder hjertet). 
The main measure of effectiveness was the proportion of patients who died or had an ‘ischaemic event' (restriction of blood supply to an organ, including the heart).
Blodpropper kan være et problem, når blodets strømning forstyrres. 
Blood clotting can be a problem when blood flow is disturbed in any way.
Udvalget anbefalede udstedelse af en markedsføringstilladelse for Quixidar. 
The Committee recommended that Quixidar be given marketing authorisation.
Når dette stof blokeres, kan der ikke dannes trombin (en anden faktor), og derfor størkner blodet ikke. 
When this is blocked, no thrombin (another factor) can be produced, and no clot can be formed.
Quixidar anbefales ikke til patienter, som står over for at skulle gennemgå visse former for PCI. 
Quixidar is not recommended in patients who are about to undergo certain types of PCI.
Ved at reducere blodpropperne kan Quixidar også medvirke til at opretholde blodtilførslen til hjertet hos patienter med angina, eller som får et hjerteanfald. 
By reducing blood clots, Quixidar can also help the flow of blood to the heart to be maintained in patients with angina or who are having a heart attack.
Quixidar er muligvis ikke egnet til patienter med nyreproblemer, eller den lavere dosis på 1,5 mg kan anvendes. 
For patients who have kidney problems, Quixidar may not be suitable, or the lower 1.5-mg dose may be used.
I undersøgelsen af myokardieinfarkt med ST-segmentforhøjelse reducerede Quixidar risikoen for død eller endnu et hjerteanfald med 14 % efter 30 dage i sammenligning med en standardbehandling. 
In the study of myocardial infarction with ST segment elevation, Quixidar reduced the risk of death or another heart attack by 14% after 30 days, compared to standard care.
Quixidar er et antikoagulerende middel: det forhindrer blodet i at koagulere (størkne). 
Quixidar is an anticoagulant; it prevents the blood from coagulating (clotting).
Quixidar indeholder det aktive stof fondaparinuxnatrium (1,5, 2,5, 5, 7,5 eller 10 mg pr. injektionssprøjte). 
Quixidar contains the active substance fondaparinux sodium (1.5, 2.5, 5, 7.5 or 10 mg per syringe).
Det kan desuden anvendes til patienter, der på grund af deres alder eller sygdommens art er i højrisikogruppen i forbindelse med abdominal kirurgi, navnlig for kræft, eller er sengeliggende på grund af akut sygdom. 
It can also be used in patients at high risk (because of their age or disease) when they have abdominal surgery, especially for cancer, or when they are forced to stay in bed because of an acute illness.
‘perkutan koronar intervention' (PCI) er en operation, som foretages for at udvide hjertets blodårer, 
‘percutaneous coronary intervention' (PCI) is an operation to unblock the heart's blood vessels,