FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: 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.
Danish: Der blev tilføjet yderligere underpunkter med information om skift mellem enoxaparinnatrium og orale antikoagulantia samt anbefalinger vedrørende administration ved spinalanæstesi/epiduralanæstesi og lumbalpunktur.
English: 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.
Danish: Til denne indikation angav de fleste af landene en enoxaparindosis på 1 mg/kg, mens enkelte lande angav lavere dosis.
English: • 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.
Danish: • 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.
English: Prophylaxis of VTE in medical patients
Danish: Profylakse af VTE hos medicinske patienter
English: • the scope of the referral was the harmonisation of the product information,
Danish: • indbringelsen vedrører harmonisering af produktinformationen,
English: 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.
Danish: 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.
English: • 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 );
Danish: • anamnese med immunmedieret heparininduceret trombocytopeni (HIT) inden for de seneste 100 dage, eller tilstedeværelse af cirkulerende antistoffer (se også punkt 4.4)
English: 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:
Danish: 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:
English: 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.
Danish: 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.
English: • careful biological monitoring by anti-Xa activity measurement in renally impaired patients;
Danish: • nøje biologisk overvågning med måling af anti-Xa-aktivitet hos patienter med nedsat nyrefunktion
English: 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.
Danish: 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.
English: The strength of the product is expressed differently in the different MSs, either in mg or in activity IU anti-factor Xa.
Danish: Lægemidlets styrke angives forskelligt i de forskellige medlemsstater, enten som mg eller som aktivitet i IE antifaktor Xa.
English: • 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);
Danish: • spinalanæstesi eller epidural anæstesi eller locoregional anæstesi, når enoxaparinnatrium anvendes til behandling de foregående 24 timer (med henvisning til punkt 4.4)
English: • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients;
Danish: • overfølsomhed over for enoxaparinnatrium, heparin eller derivater heraf, herunder andre hepariner med lav molekylvægt (LMWH) eller over for et eller flere af hjælpestofferne
English: • 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,
Danish: • 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,
English: 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.
Danish: 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.
English: In general, the sub-sections on posology and method of administration were aligned with the harmonised indications for enoxaparin.
Danish: Underpunkterne om dosering og administration blev overordnet rettet ind efter de harmoniserede indikationer for enoxaparin.
English: 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.
Danish: 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.
English: • to be used with extreme caution in patients with a history (>100 days) of heparin-induced thrombocytopenia without circulating antibodies;
Danish: • yderste forsigtighed skal udvises hos patienter med tidligere (>100 dage) heparininduceret trombocytopeni uden cirkulerende antistoffer
English: 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.
Danish: CHMP fandt imidlertid, at produktresuméet burde anbefale acetylsalicylsyre, 75 mg til 325 mg, i overensstemmelse med de kliniske data og klinisk praksis.
English: • The pen presentation (10 x 4,000 IU (10x 40 mg)) contains all approved indications except use in extracorporeal dialysis.
Danish: • pakningen med pen (10 x 4 000 IE (10x 40 mg)) omfatter alle godkendte indikationer bortset fra ekstrakorporal dialyse
English: Treatment of DVT and pulmonary embolism PE
Danish: Behandling af DVT og lungeemboli
English: Dosing in prophylaxis of venous thromboembolism in medical patients was harmonised to be aligned with ACCP guidelines.
Danish: Doseringen ved profylakse af venøs tromboembolisme hos medicinske patienter blev harmoniseret i henhold til ACCP-retningslinjerne.
English: • reduction of dosage in patients above 75 years old treated by enoxaparin for ST-segment elevation myocardial infarction (STEMI);
Danish: • nedsættelse af doseringen til patienter, der er over 75 år og behandles med enoxaparin for myokardieinfarkt med elevation af ST-segmentet (STEMI)
English: Treatment of unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI)
Danish: Behandling af ustabil angina (UA) og myokardieinfarkt uden elevation af ST-segmentet (NSTEMI)
English: 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.
Danish: 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.
English: • 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;
Danish: • anvendelse af enoxaparin frarådes hos patienter med terminal nyresygdom på grund af manglende data hos denne population, bortset fra forebyggelse af trombedannelse hos dialysepatienter
English: 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.
Danish: 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.
English: The regimen should be selected by the physician based on an individual assessment including evaluation of the thromboembolic risk and the bleeding risk.
Danish: dosisregimet bør vælges af lægen efter en individuel vurdering, herunder vurdering af den tromboemboliske risiko og blødningsrisikoen
English: 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.
Danish: 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.
English: 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.
Danish: 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).
English: 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.
Danish: 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.
English: • the Committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the product information,
Danish: • udvalget gennemgik alle data, som markedsføringstilladelsesindehaveren havde forelagt til underbygning af den foreslåede harmonisering af produktinformationen,
English: Treatment of acute ST-segment elevation myocardial infarction (STEMI)
Danish: Behandling af akut myokardieinfarkt med elevation af ST-segmentet (STEMI)
English: 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.
Danish: CHMP fandt desuden, at lægen burde vælge dosisregime ud fra en individuel vurdering, herunder vurdering af den tromboemboliske risiko og blødningsrisikoen.
English: 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.
Danish: 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.
English: • 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).
Danish: • 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Some disharmonies existed further in terms of the timing of enoxaparin administration in this indication, which were aligned as part of the procedure.
Danish: Hvad angår administrationstidspunktet for enoxaparin ved denne indikation var der visse yderligere uoverensstemmelser, der blev ophævet som led i proceduren.
English: Prophylaxis of venous thromboembolic disease
Danish: Profylakse af venøs tromboembolisk sygdom
English: • The Summary of Product Characteristics (SmPC) and Package Leaflet (PL) covering vials, ampoules and prefilled syringes covers all approved indications,
Danish: • produktresuméet og indlægssedlen for hætteglas, ampuller og fyldte sprøjter omfatter alle godkendte indikationer,
English: • 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;
Danish: • 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
English: However, no further important differences exist for the haemodialysis indication in the national SmPCs approved in the EU MSs.
Danish: For indikationen hæmodialyse er der imidlertid ikke yderligere vigtige forskelle mellem de nationale produktresuméer i EU's medlemsstater.
English: • 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.
Danish: • 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.
English: • increase in the risk of hepatic impairment;
Danish: • forhøjet risiko for nedsat leverfunktion
English: 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.
Danish: 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
English: The terminology used for the indication prophylaxis of venous thromboembolism in medical patients varied across Member States.
Danish: Der var forskelle i medlemsstaternes terminologi for indikationen profylakse af venøs tromboembolisme hos medicinske patienter.
English: Prophylaxis of venous thromboembolism (VTE) in surgical patients
Danish: Profylakse af venøs tromboembolisme (VTE) hos operationspatienter
English: 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.
Danish: 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.
English: Treatment of deep venous thromboembolism
Danish: Behandling af dyb venøs tromboembolisme
English: Prevention of thrombus formation during haemodialysis
Danish: Forebyggelse af trombedannelse under hæmodialyse
English: • not to use perform spinal/epidural anaesthesia or lumbar puncture during treatment with enoxaparin;
Danish: • under behandling med enoxaparin må der ikke foretages spinalanæstesi/epiduralanæstesi eller lumbalpunktur
English: Prevention of extracorporeal thrombus during haemodialysis
Danish: Forebyggelse af ekstrakorporal trombe under hæmodialyse
English: o or as twice daily injections of 100 IU/kg (1 mg/kg): used in all other patients such as those with obesity, with symptomatic PE, cancer, recurrent VTE or proximal (vena iliaca) thrombosis.
Danish: • Doseringen ved behandling af dyb venetrombose (DVT) og lungeemboli er blevet præciseret således: Enoxaparinnatrium kan administreres subkutant: o enten som én injektion dagligt af 150 IE/kg (1,5 mg/kg): anvendes hos patienter uden komplikationer med lav risiko for recidiv af VTE o eller som to daglige injektioner af 100 IE/kg (1 mg/kg): anvendes til alle andre patienter såsom adipøse patienter, patienter med symptomatisk lungeemboli, kræft, recidiverende VTE eller proksimal trombose (vena iliaca)
English: Some Member States had a contra-indication for severe renal impairment (clearance < 30 mL/min) in the therapeutic indications, which has been removed as part of the referral based on available data supporting use in this population.
Danish: kontraindikation ved de terapeutiske indikationer; ved indbringelsesproceduren er dette slettet på grundlag af foreliggende data, der underbygger anvendelsen hos denne population.
English: Finally a wording was added to foster traceability of biological medicinal products.
Danish: • behandlingen skal seponeres ved optræden af hudnekrose og kutan vaskulitis Endelig blev der tilføjet en ordlyd til af sporbarheden af biologiske lægemidler.
English: It is available as tablets (2.5, 5, 7.5, 10, 15 and 20 mg).
Danish: Det fås som tabletter (2,5 mg, 5 mg, 7,5 mg, 10 mg, 15 mg og 20 mg).
English: The full EPAR for Olanzapine Glenmark can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Olanzapin Glenmark findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Olanzapine Glenmark.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Olanzapine Glenmark.
English: The European Commission granted a marketing authorisation valid throughout the EU for Olanzapine Glenmark on 3 December 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Olanzapine Glenmark den 3. december 2009.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Olanzapine Glenmark.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Olanzapine Glenmark skal anvendes.
English: For more information about treatment with Olanzapine Glenmark, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Olanzapine Glenmark, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that Olanzapine Glenmark is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zyprexa.
Danish: Det betyder, at Olanzapine Glenmark er identisk med et »referencelægemiddel«, som allerede er godkendt i Den Europæiske Union (EU), og som hedder Zyprexa.
English: The recommended starting dose of Olanzapine Glenmark depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Danish: Der anvendes 10 mg om dagen til skizofreni og forebyggelse af maniske episoder og 15 mg om dagen til behandling af maniske episoder, medmindre det anvendes sammen med andre lægemidler.
English: Olanzapine Glenmark is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Danish: Olanzapine Glenmark anvendes endvidere til at behandle moderate til svære maniske episoder (ekstremt højt humør) hos voksne.
English: The CHMP concluded that, in accordance with EU requirements, Olanzapine Glenmark has been shown to have comparable quality and to be bioequivalent to Zyprexa.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Olanzapine Glenmark er af sammenlignelig kvalitet og er bioækvivalent med Zyprexa.
English: Olanzapine Glenmark is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Danish: Olanzapine Glenmark er også effektivt i fastholdelsen af den kliniske bedring ved fortsat behandling af patienter, der har reageret på den indledende behandling.
English: Olanzapine Glenmark is used to treat adults with schizophrenia.
Danish: Olanzapine Glenmark anvendes til behandling af voksne med skizofreni.