natgillin/translations-raw huggingface dataset:
I betragtning af risikoen for medicineringsfejl og for at præcisere indikationer og kontraindikationer vedtog CHMP følgende hovedpunkter i en direkte henvendelse til sundhedspersoner (DHPC) til praktiserende læger, ortopædkirurger, internmedicinere, kardiologer, hæmatologer, kirurger, farmaceuter, sygeplejersker (eller andre, alt efter det nationale sundhedssystem): 
Taking into account the risk of medication errors and the clarification as regards indications and contraindications, the CHMP agreed the following key messages to be used in a direct healthcare professional communication (DHPC) to general practitioners, orthopaedics, internists, cardiologists, haematologists, surgeons, pharmacists, nurses (or other as per national health care system):
CHMP vedtog en ordlyd, der er i overensstemmelse med de kliniske data og behandlingsretningslinjer (grad IIbB i ESC-retningslinjerne fra 2012, og 2011-retningslinjen fra American Heart Association (AHA)). 
The CHMP adopted a wording, which is in agreement with the clinical data and treatment guidelines (grade IIbB in ESC guidelines 2012, American Heart Association (AHA) guideline 2011).
- patienter, hos hvem PCI kunne blive aktuelt når som helst ved svigtende fibrinolyse eller akut recidiverende myokardieiskæmi/myokardieinfarkt, men havde måttet udskydes i andre situationer i mindst 48 timer. 
Patients in whom PCIs could be performed at any time for failed fibrinolysis or urgently in case of recurrent myocardial ischemia/infarction, but had to be deferred in other situations at least for 48 hours.
- patienter, der behandledes medicinsk (uden at undergå en primært invasiv procedure, såsom perkutan koronarintervention (PCI) eller koronar bypass-operation (CABG)) 
- Medically managed patients (not undergoing primarily invasive procedure such as percutaneous coronary intervention (PCI) or coronary bypass artery surgery (CABG);
I forbindelse med denne indikation noterede CHMP sig konsensusdokumentet fra Joint ESC/American College of Cardiology Committee med henblik på omdefinering af myokardieinfarkt (MI), hvorved definitionen af akutte koronarsyndromer blev revideret til UA og NSTEMI. 
In view of this indication, the CHMP noted the consensus document of the Joint ESC/American College of Cardiology Committee for the redefinition of myocardial infarction (MI), which led to the revision of the definition of acute coronary syndromes (ACS) to UA and NSTEMI.
Den harmoniserede indikation er baseret på behandlingsretningslinjer (European Society of Cardiology (ESC), og ACCP) samt kliniske undersøgelser og litteraturdata forelagt af markedsføringstilladelsesindehaveren. 
The harmonised indication is based on treatment guidelines (European Society of Cardiology (ESC), and ACCP), as well as clinical study and literature data presented by the MAH.
Lovenox og relaterede navne, injektionsvæske, opløsning, er aktuelt godkendt i over 140 lande verden over, herunder alle medlemsstater i Den Europæiske Union (EU) samt Norge og Island. 
Lovenox and associated names solution for injection is currently approved in more than 140 countries worldwide including all the European Union (EU) member states as well as Norway and Iceland.
• anvendelse af flerdosishætteglas indeholdende benzylalkohol hos nyfødte eller præmature nyfødte på grund af risikoen for gasping syndrom hos denne population 
• use of multiple dose vials containing benzyl alcohol in newborns or premature neonates due to risk of gasping syndrome in this population.
Blandt enoxaparins vigtigste farmakologiske egenskaber er antifaktor Xa og antifaktor IIa (antitrombin)-aktiviteten, der beror på bindingsaffiniteten til antitrombin. 
The principal pharmacological properties of enoxaparin include antifactor Xa and antifactor IIa (antithrombin) activity, which are dependent on its binding affinity for antithrombin.
• gastrointestinalt ulcus, malign neoplasme med høj blødningsrisiko, nylig hjerne-, spinaleller øjenkirurgi, kendte esofagusvaricer eller mistanke herom, arteriovenøse misdannelser, vaskulære aneurismer og større intraspinale eller intracerebrale vaskulære abnormiteter 
• gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities;
Dette punkt blev harmoniseret af hensyn til forskellene i den nøjagtige ordlyd af indikationerne til profylakse og behandling. 
The section was harmonised to address variations in the exact wording in prophylaxis and treatment indications.
Også for denne indikation henviste CHMP til de gældende ACCP-retningslinjer og foretrak en ordlyd, der stemmer bedre overens med de nuværende anbefalinger for tromboprofylakse hos akut syge medicinske patienter i litteraturen. 
The CHMP referred also for this indication to the existing ACCP guidelines, and further preferred a wording more in line with the current recommendations for thromboprophylaxis in acutely ill medical patients in the literature.
De foretagne ændringer af produktresuméet blev konsekvent afspejlet i etiketteringen i relevant omfang, dog blev de fleste punkter overladt til national udarbejdelse. 
Changes introduced in the SmPC were consistently reflected in the labelling where relevant, however some sections were left to be completed nationally.
De kliniske undersøgelser har omfattet doser mellem 0,5 mg/kg og 1,25 mg/kg. 
Doses studied in the clinical studies vary from 0.5 mg/kg to 1.25 mg/kg.
På grund af divergenser mellem oplysningerne i medlemsstaterne blev der også ajourført andre underpunkter, herunder pædiatrisk population, ældre og nedsat lever- og nyrefunktion, i overensstemmelse med de vedtagne indikationer og baseret på de foreliggende data for disse populationer. 
Due to divergent information across Member States, updates were also made in further subsections including paediatric population, elderly, hepatic and renal impairment in line with the agreed indications and based on available data in these populations.
Der blev tilføjet yderligere underpunkter med information om skift mellem enoxaparinnatrium og orale antikoagulantia samt anbefalinger vedrørende administration ved spinalanæstesi/epiduralanæstesi og lumbalpunktur. 
Further sub-sections were added to provide information on switch between enoxaparin sodium and oral anticoagulants as well as recommendations for administration in spinal/epidural anaesthesia or lumbar puncture.
Til denne indikation angav de fleste af landene en enoxaparindosis på 1 mg/kg, mens enkelte lande angav lavere dosis. 
In terms of posology for this indication most of the countries stated a dose of enoxaparin 1mg/kg and a few countries stated a lower dose for this indication.
• Styrken af enoxaparin vil nu blive angivet både i internationale enheder (IE) anti-Xaaktivitet og i mg: 1 mg enoxaparinnatrium svarer til 100 IE anti-Xa-aktivitet. 
• Enoxaparin strength will now be expressed both in international units (IU) of anti-Xa activity and in milligram (mg): One mg of enoxaparin sodium is equivalent to 100 IU anti-Xa activity.
Profylakse af VTE hos medicinske patienter 
Prophylaxis of VTE in medical patients
• indbringelsen vedrører harmonisering af produktinformationen, 
• the scope of the referral was the harmonisation of the product information,
CHMP vedtog at anvende denne definition i mærkningen på enoxaparin, og indikationen blev harmoniseret til at omfatte behandling af ustabil angina og NSTEMI ved administration sammen med oral acetylsalicylsyre. 
The CHMP agreed to use this definition in the enoxaparin labelling, and the indication was harmonised to include treatment of unstable angina and NSTEMI administered concurrently with oral acetylsalicylic acid.
• anamnese med immunmedieret heparininduceret trombocytopeni (HIT) inden for de seneste 100 dage, eller tilstedeværelse af cirkulerende antistoffer (se også punkt 4.4) 
• History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies (see also section 4.4 );
Vedrørende behandling af akut myokardieinfarkt med elevation af ST-segmentet bemærkede CHMP, at hovedundersøgelsen (ExTRACT-TIMI 25) blev udført hos STEMI-patienter, der opfyldte følgende kriterier: 
For treatment of acute ST-segment elevation myocardial infarction, the CHMP noted that the pivotal study (ExTRACT-TIMI 25) was carried out in STEMI patients fulfilling the following criteria:
Produktresuméet blev rettet ind, så det angiver den anbefalede dosis på 1 mg/kg, som er godkendt i de fleste lande og er i overensstemmelse med de kliniske data og med anbefalingerne i behandlingsvejledninger. 
The SmPC was aligned to state the recommended dose as accepted in most countries of 1mg/kg, which is in line with the clinical data and with the recommendations from treatment guidelines.
• nøje biologisk overvågning med måling af anti-Xa-aktivitet hos patienter med nedsat nyrefunktion 
• careful biological monitoring by anti-Xa activity measurement in renally impaired patients;
Den harmoniserede indikation angiver derfor profylakse af venøse tromboembolisk sygdom hos operationspatienter med moderat og høj risiko, navnlig ved ortopædkirurgi eller almen kirurgi, herunder kræftoperationer. 
The harmonised indication therefore states prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery.
Lægemidlets styrke angives forskelligt i de forskellige medlemsstater, enten som mg eller som aktivitet i IE antifaktor Xa. 
The strength of the product is expressed differently in the different MSs, either in mg or in activity IU anti-factor Xa.
• spinalanæstesi eller epidural anæstesi eller locoregional anæstesi, når enoxaparinnatrium anvendes til behandling de foregående 24 timer (med henvisning til punkt 4.4) 
• spinal or epidural anaesthesia or loco-regional anaesthesia when enoxaparin sodium is used for treatment in the previous 24 hours (with a reference to section 4.4);
• overfølsomhed over for enoxaparinnatrium, heparin eller derivater heraf, herunder andre hepariner med lav molekylvægt (LMWH) eller over for et eller flere af hjælpestofferne 
• Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients;
• pakningen med 10 000 IE (100 mg)/10 ml injektionsvæske, opløsning, anvendes kun til ekstrakorporal dialyse, hvorfor kun denne indikation dækkes af punkt 4.1, 
• The presentation 10,000 IU (100 mg)/10 mL solution for injection is used only for extracorporeal dialysis, and hence only this indication is covered in section 4.1,
For fyldte sprøjter på 0,4 ml vil styrken f.eks. blive angivet således: <Lokalt særnavn> 4 000 IE (40 mg)/0,4 ml injektionsvæske, opløsning. 
For example, for pre-filled syringes of 0.4 ml, the strength will appear as: <Local tradename> 4,000 IU (40 mg)/0.4 ml solution for injection.
Underpunkterne om dosering og administration blev overordnet rettet ind efter de harmoniserede indikationer for enoxaparin. 
In general, the sub-sections on posology and method of administration were aligned with the harmonised indications for enoxaparin.
Indikationen forebyggelse af ekstrakorporal trombedannelse under hæmodialyse var omfattet af produktinformationen i alle medlemsstater bortset fra Nederlandene, som på tidspunktet for den oprindelige markedsføringstilladelse ikke fandt dataene tilstrækkelige i forhold til det foreslåede doseringsskema. 
In view of prevention of extracorporeal thrombus during haemodialysis, all Member States had this indication in the PI, except the Netherlands who did not find the data using the dosing scheme proposed at the time of initial Marketing authorisation sufficient.
• yderste forsigtighed skal udvises hos patienter med tidligere (>100 dage) heparininduceret trombocytopeni uden cirkulerende antistoffer 
• to be used with extreme caution in patients with a history (>100 days) of heparin-induced thrombocytopenia without circulating antibodies;
CHMP fandt imidlertid, at produktresuméet burde anbefale acetylsalicylsyre, 75 mg til 325 mg, i overensstemmelse med de kliniske data og klinisk praksis. 
However, the CHMP considered that acetylsalicylic acid (ASA) should be recommended at dose from 75 mg to 325 mg in the SmPC to be in line with clinical data and clinical practice.
• pakningen med pen (10 x 4 000 IE (10x 40 mg)) omfatter alle godkendte indikationer bortset fra ekstrakorporal dialyse 
• The pen presentation (10 x 4,000 IU (10x 40 mg)) contains all approved indications except use in extracorporeal dialysis.
Behandling af DVT og lungeemboli 
Treatment of DVT and pulmonary embolism PE
Doseringen ved profylakse af venøs tromboembolisme hos medicinske patienter blev harmoniseret i henhold til ACCP-retningslinjerne. 
Dosing in prophylaxis of venous thromboembolism in medical patients was harmonised to be aligned with ACCP guidelines.
• nedsættelse af doseringen til patienter, der er over 75 år og behandles med enoxaparin for myokardieinfarkt med elevation af ST-segmentet (STEMI) 
• reduction of dosage in patients above 75 years old treated by enoxaparin for ST-segment elevation myocardial infarction (STEMI);
Behandling af ustabil angina (UA) og myokardieinfarkt uden elevation af ST-segmentet (NSTEMI) 
Treatment of unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI)
Lægemidlet er på nuværende tidspunkt registreret i EU i koncentrationerne 100 mg/ml (ækvivalent med 10 000 IE antiXa/ml) i fyldte sprøjter, flerdosishætteglas og ampuller, samt 150 mg/ml (ækvivalent med 15 000 IE antiXa/ml) i fyldte sprøjter. 
The product is currently registered in the EU under concentrations of 100 mg/mL (equivalent to 10 000 IU anti Xa/mL) in prefilled syringes, multi-dose vials, ampoules, and 150 mg/mL (equivalent to 15 000 IU anti Xa/mL) in prefilled syringes.
• anvendelse af enoxaparin frarådes hos patienter med terminal nyresygdom på grund af manglende data hos denne population, bortset fra forebyggelse af trombedannelse hos dialysepatienter 
• use of enoxaparin is not recommended for patients with end stage renal disease due to lack of data in this population outside the prevention of thrombus formation in dialysis patients;
Vedrørende denne indikation hos operationspatienter med moderat og høj risiko fandt CHMP, at produktresuméet burde afspejle, at patientens individuelle tromboemboliske risiko kan vurderes ved hjælp af en valideret risikostratificeringsmodel. 
For this indication in moderate and high risk surgical patients the CHMP considered that the SmPC should reflect that individual thromboembolic risk for patients can be estimated using a validated risk stratification model.
dosisregimet bør vælges af lægen efter en individuel vurdering, herunder vurdering af den tromboemboliske risiko og blødningsrisikoen 
The regimen should be selected by the physician based on an individual assessment including evaluation of the thromboembolic risk and the bleeding risk.
Vedrørende behandling af DVT og lungeemboli fandt CHMP på grundlag af de forelagte data og de tilgængelige behandlingsretningslinjer, at den harmoniserede ordlyd burde bestå i en daglig engangsdosis med injektion af 150 IE/kg (1,5 mg/kg) eller to daglige injektioner af 100 IE/kg (1 mg/kg) til patienter med DVT eller lungeemboli. 
For treatment of DVT and PE the CHMP considered, based on the data provided and available treatment guidelines, that the harmonised wording should include a once daily injection of 150 IU/kg (1.5 mg/kg) or a twice daily injections of 100 IU/kg (1 mg/kg) in DVT and PE patients.
For profylakse af venøs tromboembolisme (VTE) hos operationspatienter fandt CHMP, at det ville være relevant at angive indikationen i henhold til patientens tromboserisiko efter retningslinjerne fra American College of Clinical Pharmacy (ACCP). 
For prophylaxis of venous thromboembolism (VTE) in surgical patients, the CHMP considered that it would be relevant to label the indication on the patient's level of thrombotic risk in line with the American College of Clinical Pharmacy (ACCP) Guidelines.
En tidligere kontraindikation ved anvendelse hos patienter med terminal nyresygdom (kreatininclearance <15 ml/min) blev ligeledes slettet, da der manglede sikkerhedsdata hos denne population som begrundelse for en kontraindikation; dog frarådes anvendelse hos denne population som omhandlet nedenfor. 
A previously existing contraindication for use in patients with end stage renal disease (creatinine clearance <15 mL/min) was also removed due to lack of safety data in this population justifying a contraindication, however use in this population is not recommended, as outlined below.
• udvalget gennemgik alle data, som markedsføringstilladelsesindehaveren havde forelagt til underbygning af den foreslåede harmonisering af produktinformationen, 
• the Committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the product information,
Behandling af akut myokardieinfarkt med elevation af ST-segmentet (STEMI) 
Treatment of acute ST-segment elevation myocardial infarction (STEMI)
CHMP fandt desuden, at lægen burde vælge dosisregime ud fra en individuel vurdering, herunder vurdering af den tromboemboliske risiko og blødningsrisikoen. 
The CHMP also considered that the regimen should be selected by the physician based on an individual assessment including evaluation of the thromboembolic risk and of the risk of bleeding.
For behandling af dyb venøs tromboembolisme afveg den nøjagtige ordlyd af indikationen mellem medlemsstaterne, og CHMP overvejede at harmonisere den til at omfatte behandling af dyb venetrombose (DVT) og lungeemboli, herunder lungeemboli, der kan forventes at kræve trombolytisk behandling eller operation. 
For treatment of deep venous thromboembolism, the exact wording varied across Member States, and the CHMP considered harmonising the indication to include treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) excluding PE likely to require thrombolytic therapy or surgery.
• udvalget vedtog en harmoniseret produktinformation for Lovenox og relaterede navne, anbefalede CHMP ændring af betingelserne for de markedsføringstilladelser, for hvilke produktinformationen fremgår af bilag III for Lovenox og relaterede navne (se bilag I), konkluderede CHMP, at benefit/risk-forholdet for Lovenox og relaterede navne fortsat er positivt, forudsat at de vedtagne ændringer af produktinformationen gennemføres. 
• the Committee agreed on a harmonised product information for Lovenox and associated names, the CHMP recommended the variation to the terms of the marketing authorisations for which the product information is set out in Annex III for Lovenox and associated names (see Annex I).
CHMP bemærkede, at de gældende ESC-retningslinjer anbefaler acetylsalicylsyre til alle patienter uden kontraindikationer med en initialdosis på 150-300 mg (hos ikke tidligere acetylsalicylsyre-behandlede patienter) og en vedligeholdende langtidsdosis på 75-100 mg/dag, uanset behandlingsstrategien. 
The CHMP noted that in the current ESC guideline, ASA is recommended for all patients without contraindications at an initial oral loading dosed of 150-300 mg (in aspirin-naive patients) and a maintenance dose of 75-100 mg/day longterm regardless of the treatment strategy.
Derudover er hætteglas med 100 mg/10 ml og en pen med 10 x 40 mg (ækvivalent med 10 x 4 000 IE antiXa) godkendt. 
Vials of 100 mg/10 mL and a pen of 10 x 40 mg (equivalent to 10 x 4 000 IU anti Xa) are also authorised.
Hvad angår administrationstidspunktet for enoxaparin ved denne indikation var der visse yderligere uoverensstemmelser, der blev ophævet som led i proceduren. 
Some disharmonies existed further in terms of the timing of enoxaparin administration in this indication, which were aligned as part of the procedure.
Profylakse af venøs tromboembolisk sygdom 
Prophylaxis of venous thromboembolic disease
• produktresuméet og indlægssedlen for hætteglas, ampuller og fyldte sprøjter omfatter alle godkendte indikationer, 
• The Summary of Product Characteristics (SmPC) and Package Leaflet (PL) covering vials, ampoules and prefilled syringes covers all approved indications,
• hos patienter med svært nedsat nyrefunktion (kreatininclearance 15-30 ml/min) anbefales dosisjustering ved terapeutiske og profylaktiske dosisregimer, da eksponeringen for enoxaparinnatrium er betydeligt øget 
• in patients with severe renal impairment (creatinine clearance 15-30 mL/min), since exposure of enoxaparin sodium is significantly increased, a dosage adjustment is recommended for therapeutic and prophylactic dosage ranges;
For indikationen hæmodialyse er der imidlertid ikke yderligere vigtige forskelle mellem de nationale produktresuméer i EU's medlemsstater. 
However, no further important differences exist for the haemodialysis indication in the national SmPCs approved in the EU MSs.
• I nogle medlemsstater var der kontraindikation ved svært nedsat nyrefunktion (kreatininclearance < 30 ml/min); denne er slettet fra produktinformationen, men anvendelse frarådes hos patienter med terminal nyresygdom (kreatininclearance <15 ml/min) ud over forebyggelse af trombedannelse hos dialysepatienter. 
• A contraindication in patients with severe renal impairment (creatinine clearance < 30 ml/min) that existed in some EU member states was removed from the Product Information, however, use in patients with end stage kidney disease (creatinine clearance <15 ml/min) is not recommended outside the prevention of thrombus formation in dialysis patients.
• forhøjet risiko for nedsat leverfunktion 
• increase in the risk of hepatic impairment;
Dette kan øge risikoen for medicineringsfejl og dermed for trombose eller større blødninger; ordlyden er derfor ændret, så styrken angives i begge enheder (IE anti-Xa/ml og det tilsvarende antal mg/ml) på yderkartonen og den indre emballage (sprøjte) og i punkt 1, 2 og 
As harmonisation of expression of strength to one of the options would have led to changes to the established practice in several countries, and as this may increase the risk of medication errors leading to higher risk of thrombosis or major bleeding, the wording has been amended to express the strength in both units (in IU anti-Xa/mL and its equivalence in mg/ml) on the outer-carton and immediate packaging (syringe) and in sections 1, 2 and 4.2.
Der var forskelle i medlemsstaternes terminologi for indikationen profylakse af venøs tromboembolisme hos medicinske patienter. 
The terminology used for the indication prophylaxis of venous thromboembolism in medical patients varied across Member States.
Profylakse af venøs tromboembolisme (VTE) hos operationspatienter 
Prophylaxis of venous thromboembolism (VTE) in surgical patients
På den anden side angives styrken af hepariner med lav molekylvægt (LMWH) i de fleste EU-medlemsstater hovedsagelig i IE anti-Xa-aktivitet og ikke i mg, hvilket er i overensstemmelse med ph. eur. 
On the other hand, other low molecular weight heparins (LMWHs) in most European MSs are mainly expressed in IU of activity anti Xa and not in mg, which is in line with the European Pharmacopoeia (Version 8.1, 2014), which expresses the strength of heparins, including LWMH in IU of activity anti Xa.
Behandling af dyb venøs tromboembolisme 
Treatment of deep venous thromboembolism
Forebyggelse af trombedannelse under hæmodialyse 
Prevention of thrombus formation during haemodialysis
• under behandling med enoxaparin må der ikke foretages spinalanæstesi/epiduralanæstesi eller lumbalpunktur 
• not to use perform spinal/epidural anaesthesia or lumbar puncture during treatment with enoxaparin;
Forebyggelse af ekstrakorporal trombe under hæmodialyse 
Prevention of extracorporeal thrombus during haemodialysis