FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE LOVENOX 10 x 4,000 IU (10 x 40 mg) Pen
Danish: INFORMATION I BRAILLESKRIFT LOVENOX 10 x 4.000 IE (10 x 40 mg) Pen
English: If you are going to have a spinal puncture or an operation where an epidural or spinal anaesthetic is used, tell you doctor that you are using LOVENOX (and associated names) .
Danish: Hvis du skal have foretaget en rygmarvspunktur eller en operation, hvor du skal have en rygmarvsbedøvelse eller epidural bedøvelse, skal du fortælle lægen, at du får LOVENOX (og relaterede navne).
English: • you are going to receive spinal or epidural anesthesia or lumbar puncture (see Operations and Anaesthetics): a delay should be respected between Lovenox use and this procedure.
Danish: • hvis du skal have en rygmarvsbedøvelse eller en epiduralbedøvelse (se ”Operationer og bedøvelse”): et tidsinterval mellem brug af Lovenox og denne procedure skal overholdes
English: The treatment benefits of enoxaparin sodium, evident for a number of efficacy outcomes, emerged at 48 hours, at which time there was a 35 percent reduction in the relative risk of myocardial reinfarction, as compared with treatment with unfractionated heparin (p<0.001).
Danish: De terapeutiske fordele ved enoxaparinnatrium, der var evident for et antal effektmål, sås efter 48 timer, hvor den relative risikoreduktion for nyt myokardieinfarkt var 35 % sammenlignet med behandling med ufraktioneret heparin (p < 0,001).
English: The safety and efficacy of LOVENOX (and associated names) has not been evaluated in children or adolescents.
Danish: Brug til børn og unge LOVENOX' (og relaterede navne) sikkerhed og virkning er ikke undersøgt hos børn og unge.
English: VTE = venous thromboembolic event (DVT and/or PE) *The 95% Confidence Intervals for the treatment differences for total VTE were: - Enoxaparin sodium once a day versus heparin (-3.0 to 3.5) - enoxaparin sodium every 12 hours versus heparin (-4.2 to 1.7).
Danish: VTE = venetromboembolisk hændelse (DVT og/eller PE) *95 % konfidensintervaller for behandlingsforskelle for totalt antal VTE var: - enoxaparinnatrium en gang dagligt versus heparin (-3,0 til 3,5) - enoxaparinnatrium hver 12. time versus heparin (-4,2 til 1,7).
English: LOVENOX (and associated names) can be used for two different types of heart attack called STEMI (ST segment elevation myocardial infarction) or Non-STEMI (NSTEMI).
Danish: LOVENOX (og relaterede navne) kan anvendes ved to forskellige former for hjerteanfald, STEMI (myokardieinfarkt med ST-elevation) eller non-STEMI (NSTEMI, myokardieinfarkt uden STelevation).
English: Based on literature data the use of enoxaparin sodium 4,000 IU (40 mg) in cirrhotic patients (ChildPugh class B-C) appears to be safe and effective in preventing portal vein thrombosis.
Danish: Baseret på data fra litteraturen synes det at være sikkert og effektivt at bruge enoxaparin 4.000 IE (40 mg) til forebyggelse af portal venetrombose hos patienter med cirrose (Child-Pugh klasse B-C).
English: After you have had a heart attack
Danish: Efter et hjerteanfald
English: Benzyl alcohol may also cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Danish: Benzylalkohol kan ligeledes forårsage toksiske og anafylaktoide reaktioner hos spædbørn og børn op til 3 år.
English: LOVENOX (and associated names) 10,000 IU (100 mg)/10 mL is used to stop blood clots forming in the tubes of your dialysis machine (used for people with severe kidney problems).
Danish: LOVENOX (og relaterede navne) 10.000 IE (100 mg)/10 ml anvendes til at forhindre, at blodet størkner i slangerne på en dialysemaskine (bruges til personer med alvorlige nyreproblemer).
English: All Treated Extended Prophylaxis Patients
Danish: Alle patienter behandlet med forlænget profylakse VTE totalt
English: • Your doctor will decide how long you should receive LOVENOX (and associated names).
Danish: • Lægen vil afgøre, hvor længe du skal have LOVENOX (og relaterede navne).
English: LOVENOX (and associated names) should not be used interchangeably with other medicines belonging to the group of low molecular weight heparins.
Danish: LOVENOX (og relaterede navne) bør ikke umiddelbart udskiftes med anden medicin, der tilhører gruppen af lavmolekylære hepariner.
English: After repeated SC 150 IU/kg (1.5 mg/kg) once daily dosing, mean AUC of anti-Xa activity is marginally higher at steady state in obese healthy volunteers (BMI 30-48 kg/m2) compared to nonobese control subjects, while maximum plasma anti-Xa activity level is not increased.
Danish: Efter gentagne subkutane doser på 150 IE/kg (1,5 mg/kg) en gang dagligt er den gennemsnitlige AUC af anti-Xa-aktivitet ved steady state marginalt højere hos svært overvægtige, raske forsøgspersoner (BMI 30-48 kg/m2) sammenlignet med ikke-overvægtige kontrolpersoner, mens det maksimale plasmaniveau ikke er øget.
English: Marketing Authorisation Holder and Manufacturer [To be completed nationally] [See Annex I - To be completed nationally] [For referral procedures] {Name and address} {tel} {fax} {e-mail}
Danish: Indehaver af markedsføringstilladelsen og fremstiller [Udfyldes nationalt] [Se bilag I - Udfyldes nationalt] [For referral procedures] {Navn og adresse} {tlf.} {fax} {e-mail}
English: Method of administration LOVENOX (and associated names) should not be administered by the intramuscular route.
Danish: Administration LOVENOX (og relaterede navne) må ikke administreres intramuskulært.
English: If an epidural anaesthesia is planned, it is recommended to withdraw enoxaparin sodium treatment before (see section 4.4).
Danish: Hvis der er planlagt epiduralanæstesi, anbefales det at seponere enoxaparin-behandlingen før anæstesien (se pkt.
English: Your doctor will request you perform blood tests called INR and tell you when to start LOVENOX (and associated names) accordingly.
Danish: Lægen vil sørge for, at du får taget en blodprøve, der hedder INR, og vil fortælle dig, hvornår du skal starte behandlingen med LOVENOX (og relaterede navne).
English: Benzyl alcohol may also cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old (see section 4.4).
Danish: Benzylalkohol kan ligeledes medføre toksiske og anafylaktoide reaktioner hos spædbørn og børn op til 3 år (se pkt.
English: - Changing from treatment with direct oral anticoagulant to LOVENOX (and associated names) Stop taking direct oral anticoagulant.
Danish: - Skift fra direkte orale antikoagulantia til LOVENOX (og relaterede navne) Du skal stoppe med at tage den direkte orale antikoagulans.
English: SC injection
Danish: Subkutan injektion
English: See “Do not use LOVENOX (and associated names)”.
Danish: Se afsnittet ”Brug ikke LOVENOX (og relaterede navne)”.
English: Do not mix with other products.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler.
English: • LOVENOX (and associated names) is usually given by injection underneath the skin (subcutaneous).
Danish: • LOVENOX (og relaterede navne) gives normalt som en indsprøjtning under huden (subkutant).
English: Detailed information on this medicinal product is available on the website of {name of MS Agency (link)}
Danish: Yderligere oplysninger om dette lægemiddel findes på Lægemiddelstyrelsens hjemmeside.
English: Enoxaparin sodium, as with any other anticoagulant therapy, should be used with caution in conditions with increased potential for bleeding, such as: - impaired haemostasis, - history of peptic ulcer, - recent ischemic stroke, - severe arterial hypertension, recent diabetic retinopathy, - neuro- or ophthalmologic surgery, - concomitant use of medications affecting haemostasis (see section 4.5).
Danish: I lighed med andre antikoagulantia bør enoxaparinnatrium anvendes med forsigtighed ved øget blødningsrisiko som f.eks.: - nedsat hæmostase, - mavesår i anamnesen, - nylig iskæmisk apopleksi, - svær arteriel hypertension, - nylig diabetisk retinopati, - neurokirurgi eller øjenoperation, - samtidig brug af lægemidler, der påvirker hæmostasen (se pkt.
English: However, since renal function is known to decline with age, elderly patients may show reduced elimination of enoxaparin sodium (see section 4.4).
Danish: Men eftersom nyrefunktionen aftager med alderen, kan eliminationen af enoxaparinnatrium være reduceret hos ældre patienter (se pkt.
English: Like other similar medicines (medicines to reduce blood clotting), LOVENOX (and associated names) may cause bleeding which may potentially be life-threatening.
Danish: LOVENOX (og relaterede navne) kan som anden lignende medicin (blodfortyndende medicin) medføre blødning, som kan være livstruende.
English: • For acute STEMI, treatment is to be initiated with a single IV bolus injection immediately followed by a SC injection.
Danish: • Ved behandling af akut STEMI skal behandlingen starte med en enkelt intravenøs bolusinjektion, umiddelbart efterfulgt af en subkutan injektion.
English: If you receive more LOVENOX (and associated names) than you should If you think that you have received too much or too little LOVENOX (and associated names), tell your doctor, nurse or pharmacist immediately, even if you have no signs of a problem.
Danish: Hvis du har fået for meget LOVENOX (og relaterede navne) Hvis du tror, at du har fået for meget eller for lidt LOVENOX (og relaterede navne), skal du straks fortælle det til lægen, sundhedspersonalet eller apotekspersonalet, også selvom du ikke har tegn på, at det er et problem.
English: • If you have any sign of blockage of a blood vessel by a blood clot such as: - cramping pain, redness, warmth, or swelling in one of your legs - these are symptoms of deep vein thrombosis - breathlessness, chest pain, fainting or coughing up blood - these are symptoms of a pulmonary embolism
Danish: • Hvis du får tegn på, at du har fået en blodprop, f.eks.: - krampelignende smerter, rødme, varmefølelse eller hævelse i det ene ben - dette er symptomer på blodprop i en dybtliggende vene - åndenød, smerter i brystkassen, besvimelse eller ophostning af blod - dette er symptomer på en blodprop i lungerne
English: Changing of anticoagulant treatment - Changing from LOVENOX (and associated names) to blood thinners called vitamin-K antagonists (e.g. warfarin)
Danish: Skift mellem blodfortyndende medicin - Skift fra LOVENOX (og relaterede navne) til blodfortyndende medicin kaldet K-vitaminantagonister (f.eks. warfarin)
English: Dosing regimen Prophylaxis of venous thromboembolic disease 2,000 IU (20 mg) SC once daily
Danish: Dosering Profylakse mod venøs tromboembolisk sygdom 2.000 IE (20 mg) s.c. en gang dagligt
English: LOVENOX (and associated names) contains the active substance called enoxaparin sodium that is a low molecular weight heparin (LMWH).
Danish: LOVENOX (og relaterede navne) indeholder det aktive stof enoxaparinnatrium, der tilhører en gruppe lægemidler, der kaldes lavmolekylære hepariner.
English: These are more likely to appear in the area you have been injected with LOVENOX (and associated names).
Danish: Dette ses oftest i det område, hvor LOVENOX (og relaterede navne) er blevet sprøjtet ind.
English: If you use more LOVENOX (and associated names) than you should If you think that you have used too much or too little LOVENOX (and associated names), tell your doctor, nurse or pharmacist immediately, even if you have no signs of a problem.
Danish: Hvis du har brugt for meget LOVENOX (og relaterede navne) Hvis du tror, at du har taget for meget eller for lidt LOVENOX (og relaterede navne), skal du straks fortælle det til lægen, sundhedspersonalet eller apotekspersonalet, også selvom du ikke har tegn på, at det er et problem.
English: LOVENOX (and associated names) does not affect the ability to drive and operate machinery.
Danish: LOVENOX (og relaterede navne) påvirker ikke evnen til at køre bil eller motorcykel eller betjene maskiner.
English: 6.6 Special precautions for disposal and other handling [To be completed nationally]
Danish: 6.6 Regler for bortskaffelse og anden håndtering [Udfyldes nationalt]
English: [to be completed nationally]
Danish: [Udfyldes nationalt]
English: LOVENOX (and associated names) is indicated in adults for:
Danish: LOVENOX (og relaterede navne) er indiceret til voksne til:
English: LOVENOX (and associated names) in a pen can be used to:
Danish: LOVENOX (og relaterede navne) i en pen kan anvendes til:
English: : Platelet increased >400 G/L
Danish: : Forhøjet trombocyttal >400 109/l
English: • For treatment of unstable angina and NSTEMI, the recommended dose of enoxaparin sodium is 100 IU/kg (1 mg/kg) every 12 hours by SC injection administered in combination with antiplatelet therapy.
Danish: • Til behandling af ustabil angina pectoris og NSTEMI er den anbefalede dosis 100 IE/kg (1 mg/kg) enoxaparinnatrium som s.c.-injektion hver 12. time i kombination med trombocythæmmende behandling.
English: However, your doctor may give you a futher dose of 50 IU to 100 IU (0.5 to 1 mg) for every kilogram of your weight, if necessary.
Danish: Hvis det er nødvendigt, kan der dog indsprøjtes en dosis mere på 50 IE til 100 IE (0,5-1 mg) pr. kg legemsvægt.
English: Your doctor will request you perform blood tests called INR and tell you when to stop LOVENOX (and associated names) accordingly.
Danish: Lægen vil sørge for, at du får taget en blodprøve, der hedder INR, og vil fortælle dig, hvor længe du skal have LOVENOX (og relaterede navne).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 10,000 IU/10 mL (100 mg/10 mL) VIAL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER 10.000 IE/10 ml (100 mg/10 ml) HÆTTEGLAS
English: (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (< 1/10,000) or not known (cannot be estimated from available data).
Danish: 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The risk of these events is higher with the use of post-operative indwelling epidural catheters, with the concomitant use of additional drugs affecting haemostasis such as NonSteroidal-Anti Inflammatory Drugs (NSAIDs), with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity.
Danish: Risikoen er øget ved brug af postoperative epidurale katetre, ved samtidig anvendelse af lægemidler, der påvirker hæmostasen som f.eks. non-steroide antiinflammatoriske stoffer (NSAID), ved traumatiserende eller gentagen spinal- eller epiduralpunktur og hos patienter med spinalkirurgi eller spinal deformation i anamnesen.
English: Multiple Dose Vials:
Danish: Hætteglas, multidosis:
English: • Aspirin (also known as acetylsalicylic acid or ASA), clopidogrel or other medicines used to stop blood clots from forming
Danish: • Acetylsalicylsyre, clopidogrel eller andre lægemidler, der bruges til at forhindre dannelse af blodpropper
English: It must not be used in premature babies or babies up to 1 month old due to the risk of severe toxicity including abnormal respiration.
Danish: For tidligt fødte og nyfødte (op til 1 måned gamle) må ikke få benzylalkohol på grund af risikoen for alvorlig forgiftning og vejrtrækningsforstyrrelser.
English: If you forget to use LOVENOX (and associated names) If you forget to give yourself a dose, have it as soon as you remember.
Danish: Hvis du har glemt at tage LOVENOX (og relaterede navne) Hvis du har glemt at give dig selv en dosis, skal du give den, så snart du kommer i tanke om det. Du må ikke give dig selv en dobbeltdosis på den samme dag som erstatning for den glemte dosis.
English: MARKETING AUTHORISATION HOLDER [To be completed nationally] [See Annex I - To be completed nationally] {Name and address} {tel} {fax} {e-mail}
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Udfyldes nationalt] [Se bilag I - Udfyldes nationalt] {Navn og adresse}
English: In treatment of DVT with or without PE, patients receiving enoxaparin sodium were treated with either a 100 IU/kg (1 mg/kg) SC dose every 12 hours or a 150 IU/kg (1.5 mg/kg) SC dose once a day.
Danish: Ved behandling af DVT med eller uden lungeemboli fik patienterne enten 100 IE/kg (1 mg/kg) enoxaparinnatrium subkutant hver 12. time eller 150 IE/kg (1,5 mg/kg) subkutant en gang dagligt.
English: What you need to know before you use LOVENOX (and associated names)
Danish: Det skal du vide, før du begynder at bruge LOVENOX (og relaterede navne)
English: Investigations • Rare: Hyperkalaemia* (see sections 4.4 and 4.5)
Danish: Undersøgelser • Sjælden: Hyperkaliæmi* (se pkt.
English: • Percutaneous coronary revascularization procedures To minimize the risk of bleeding following the vascular instrumentation during the treatment of unstable angina, NSTEMI and acute STEMI, adhere precisely to the intervals recommended between enoxaparin sodium injection doses.
Danish: For at minimere risikoen for blødning i forbindelse med vaskulær instrumentering ved behandling af ustabil angina pectoris, NSTEMI og akut STEMI skal de anbefalede intervaller mellem enoxaparinnatrium-doserne overholdes nøje.
English: R
Danish: H
English: • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH), to benzyl alcohol or to any of the excipients listed in section 6.1;
Danish: • Overfølsomhed over for enoxaparinnatrium, heparin eller derivater heraf, inklusive andre lavmolekylære hepariner, benzylalkohol eller over for et eller flere af hjælpestofferne anført i pkt.
English: Intracranial haemorrhage, Retroperitoneal haemorrhage
Danish: Ikke almindelig: Intrakraniel blødning, Retroperitoneal blødning
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION LOVENOX 10 x 4,000 IU (10 x 40 mg) Pen enoxaparin
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) LOVENOX 10 x 4.000 IE (10 x 40 mg) Pen enoxaparin
English: Do not use LOVENOX (and associated names)
Danish: Brug ikke LOVENOX (og relaterede navne):
English: 50,000 IU (500 mg)/5 mL
Danish: 50.000 IE (500 mg)/5 ml
English: If the last SC administration was given more than 8 hours before balloon inflation, an IV bolus of 30 IU/kg (0.3 mg/kg) enoxaparin sodium should be administered.
Danish: Hvis den sidste subkutane dosis blev givet mere end 8 timer før ballonudvidelsen, skal der administrere en intravenøs bolusinjektion på 30 IE/kg (0,3 mg/kg) enoxaparinnatrium.
English: - If you have any further questions, ask your doctor or pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: o Additional bolus for PCI when last SC administration was given more than 8 hours before balloon inflation For patients being managed with PCI, an additional IV bolus of 30 IU/kg (0.3 mg/kg) is to be administered if last SC administration was given more than 8 hours before balloon inflation.
Danish: o Yderligere bolus ved PCI, når sidste subkutane administration blev givet mere end 8 timer før ballonudvidelsen Patienter, der undergår PCI, skal have en yderligere intravenøs bolusinjektion på 30 IE/kg (0,3 mg/kg) enoxaparinnatrium, hvis den sidste subkutane dosis blev givet mere end 8 timer før ballonudvidelsen.
English: 30,000 IU (300 mg) /3 mL
Danish: 30.000 IE (300 mg)/3 ml
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER PEN
English: LOVENOX (and associated names) can be used during breastfeeding.
Danish: LOVENOX (og relaterede navne) kan anvendes i ammeperioden.
English: 15,000 IU (150 mg) /1 mL
Danish: 15.000 IE (150 mg)/1 ml
English: Other medicines and LOVENOX (and associated names) Tell your doctor or pharmacist if you are taking or might take/use any other medicines.
Danish: Brug af anden medicin sammen med LOVENOX (og relaterede navne) Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: 4,000 IU (40 mg) /0.4 mL
Danish: 4.000 IE (40 mg)/0,4 ml
English: • LOVENOX (and associated names) can be added to the tube leaving the body (arterial line) at the start of the dialysis session.
Danish: • LOVENOX (og relaterede navne) kan sprøjtes ind i den slange, der udgår fra kroppen (arterieslangen), i begyndelsen af dialysebehandlingen.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX 10,000 IU/10 mL (100 mg/10 mL) VIAL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERPAKNING TIL 10.000 IE/10 ml (100 mg/10 ml) hætteglas
English: LOVENOX (and associated names) can be used to:
Danish: LOVENOX (og relaterede navne) kan anvendes til:
English: Use of enoxaparin sodium in patients with a history of immune mediated HIT within the past 100 days or in the presence of circulating antibodies is contraindicated (see section 4.3).
Danish: • Anamnese med heparin-induceret trombocytopeni (HIT) (>100 dage) Anvendelse af enoxaparinnatrium hos patienter med immunmedieret HIT inden for de seneste 100 dage eller ved tilstedeværelse af cirkulerende antistoffer er kontraindiceret (se pkt.
English: For patients with creatinine clearance [15-30 mL/minute], additional considerations are necessary because elimination of enoxaparin sodium is more prolonged.
Danish: Yderligere overvejelser kan være nødvendige hos patienter med kreatinin-clearance 15-30 ml/minut, eftersom enoxaparin elimineres langsommere.
English: 6,000 IU (60 mg) /0.6 mL
Danish: 6.000 IE (60 mg)/0,6 ml
English: • LOVENOX (and associated names) is added to the tube leaving the body (arterial line) at the start of the dialysis session.
Danish: • LOVENOX (og relaterede navne) sprøjtes ind i den slange, der udgår fra kroppen (arterieslangen), i begyndelsen af dialysebehandlingen.
English: • Spinal/Epidural anaesthesia or lumbar puncture Spinal/epidural anaesthesia or lumbar puncture must not be performed within 24 hours of administration of enoxaparin sodium at therapeutic doses (see also section 4.3).
Danish: Der må ikke udføres spinal-/epiduralanæstesi eller lumbalpunktur inden for 24 timer efter administration af terapeutiske doser enoxaparinnatrium (se også pkt.
English: Operations and Anaesthetics
Danish: Operationer og bedøvelse
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial (10.0 mL) contains 10,000 IU (100 mg) enoxaparin sodium.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et hætteglas (10,0 ml) indeholder 10.000 IE (100 mg) enoxaparinnatrium.
English: - The active substance(s) is enoxaparin sodium
Danish: - Aktivt stof: enoxaparinnatrium
English: What LOVENOX (and associated names) contains - The active substance(s) is enoxaparin sodium [To be completed nationally]
Danish: Pakningsstørrelser og yderligere oplysninger LOVENOX (og relaterede navne) indeholder: - Aktivt stof: enoxaparinnatrium [Udfyldes nationalt]
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection [to be completed nationally]
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning [Udfyldes nationalt]
English: 1 x 3,000 IU (30 mg) IV bolus plus 100 IU/kg (1 mg/kg) body weight SC and then 100 IU/kg (1 mg/kg) body weight SC every 24 hours
Danish: 1 x 3.000 IE (30 mg) i.v.-bolus plus 100 IE/kg (1 mg/kg) s.c. efterfulgt af 100 IE/kg (1 mg/kg) s.c. en gang dagligt
English: Treatment of unstable angina and non ST elevation myocardial infarction In a large multicenter study, 3,171 patients enrolled at the acute phase of unstable angina or non-Qwave myocardial infarction were randomized to receive in association with acetylsalicylic acid (100 to 325 mg once daily), either SC enoxaparin sodium 100 IU/kg (1 mg/kg) every 12 hours or IV unfractionated heparin adjusted based on aPTT.
Danish: Behandling af ustabil angina pectoris og myokardieinfarkt uden ST-elevation Et stort multicenterstudie omfattede 3.171 patienter, som blev inkluderet i den akutte fase af ustabil angina pectoris eller myokardieinfarkt uden Q-taksudvikling og blev randomiseret til at få acetylsalicylsyre (100 til 325 mg en gang dagligt) i kombination med enten enoxaparinnatrium 100 IE/kg (1 mg/kg) subkutant hver 12. time eller intravenøs infusion af ufraktioneret heparin i en dosis, der blev justeret i henhold til aPTT.
English: In patients with severe renal impairment (creatinine clearance <30 mL/min), the AUC at steady state is significantly increased on average by 65% after repeated SC 4,000 IU (40 mg) once daily doses (see section 4.4).
Danish: er AUC ved steady state signifikant øget med gennemsnitligt 65 % efter gentagne subkutane doser på 4.000 IE (40 mg) en gang dagligt (se pkt.