FrancophonIA/ELRC3.0 huggingface dataset:
English: • Stop blood clots from forming in your blood in the following situations: o When you have an acute illness and face period of limited mobility o When you have unstable angina (a condition when not enough blood gets to your heart)
Danish: • At forhindre, at der dannes blodpropper i blodet i følgende situationer: o Under en periode med begrænset bevægelighed på grund af akut sygdom o Hvis du har ustabil angina pectoris (hvor der kun kommer begrænset blod til hjertet)
English: Patients had to be treated in hospital for a minimum of 2 days and a maximum of 8 days, until clinical stabilization, revascularization procedures or hospital discharge.
Danish: Patienterne blev behandlet på hospital i 2-8 dage indtil klinisk stabilisering, revaskularisering eller udskrivning.
English: It is important for you to keep having Thorinane injections until your doctor decides to stop them.
Danish: Det er vigtigt, at du bliver ved med at få dette lægemiddel, indtil lægen siger, at du kan stoppe.
English: • Arterial line injection:
Danish: • Injektion i arterieslangen:
English: Enoxaparin sodium prophylaxis for four weeks after surgery for abdominal or pelvic cancer significantly reduced the incidence of venographically demonstrated thrombosis, as compared with enoxaparin sodium prophylaxis for one week.
Danish: Profylakse med enoxaparinnatrium i fire uger efter kirurgi for abdominal- eller bækkencancer reducerede signifikant forekomsten af trombose påvist ved flebografi sammenlignet med profylakse med enoxaparinnatrium i en uge.
English: • Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, 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;
Danish: • Aktiv, klinisk signifikant blødning og tilstande med en høj blødningsrisiko, inklusive nylig hjerneblødning, gastrointestinalt ulcus, tilstedeværelse af malignt neoplasme med høj blødningsrisiko, nylig hjerne-, ryg- eller øjenkirurgi, øsofageale varicer eller mistanke herom, arteriovenøse misdannelser, vaskulære aneurismer eller svære intraspinale eller intracerebrale
English: The beneficial effect of enoxaparin sodium on the primary end point was consistent across key subgroups including age, gender, infarct location, history of diabetes, history of prior myocardial infarction, type of fibrinolytic administered, and time to treatment with study drug.
Danish: Enoxaparinnatriums gavnlige virkning på det primære effektmål var konstant i alle vigtige undergrupper, herunder alder, køn, fokus for myokardieinfarkt, diabetes i anamnesen, myokardieinfarkt i anamnesen, det administrerede fibrinolytikum samt tid til behandlingsstart med studielægemidlet.
English: • Switch between enoxaparin sodium and direct oral anticoagulants (DOAC) For patients currently receiving enoxaparin sodium, discontinue enoxaparin sodium and start the DOAC 0 to 2 hours before the time that the next scheduled administration of enoxaparin sodium would be due as per DOAC label.
Danish: • Skift mellem enoxaparinnatrium og direkte orale antikoagulantia (DOAK) Hos patienter, der får enoxaparinnatrium, seponeres enoxaparinnatrium, og DOAK indledes 0 til 2 timer før det tidspunkt, hvor den næste planlagte administration af enoxaparinnatrium skulle foregå i overensstemmelse med vejledningen for DOAK.
English: Enoxaparin sodium is a biological substance obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa.
Danish: Enoxaparinnatrium er et biologisk stof, der er fremstillet ved alkalisk depolymerisering af heparinbenzylester udvundet fra tarmmucosa fra svin.
English: • Thorinane can be given by injection into your vein (intravenous) after certain types of heart attack or operation.
Danish: • Thorinane kan gives som en indsprøjtning i en vene (intravenøst) efter bestemte typer hjerteanfald
English: At doses used for prophylaxis of venous thromboembolism, enoxaparin sodium does not influence bleeding time and global blood coagulation tests significantly, nor does it affect platelet aggregation or binding of fibrinogen to platelets.
Danish: Ved doser anvendt profylaktisk mod venøs tromboemboli påvirker enoxaparinnatrium ikke blødningstiden og generelle koagulationsparametre i signifikant grad, og det påvirker heller ikke trombocytaggregation eller binding af fibrinogen til trombocytter.
English: Your doctor will request you perform blood tests called INR and tell you when to start Thorinane 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
English: When non-weight adjusted dosing was administered, it was found after a single-SC 4,000 IU (40 mg) dose, that anti-Xa exposure is 52% higher in low-weight women (<45 kg) and 27% higher in low-weight men (<57 kg) when compared to normal weight control subjects (see section 4.4).
Danish: Ved administration af ikke-vægtjusterede doser fandt man, at efter en enkelt subkutan dosis på 4.000 IE (40 mg) var eksponeringen for anti-Xa 52 % højere hos kvinder med lav vægt (<45 kg) og 27 % højere hos mænd med lav vægt (<57 kg) sammenlignet med normalvægtige kontrolpersoner (se pkt.
English: Animal studies have not shown any evidence of foetotoxicity or teratogenicity (see section 5.3).
Danish: Dyrestudier har ikke påvist evidens for føtotoksicitet eller teratogenicitet (se pkt.
English: Do not press on the plunger before injecting yourself to get rid of air bubbles.
Danish: Tryk ikke på stemplet for at fjerne luftbobler, før du giver dig selv indsprøjtningen.
English: • Extended prophylaxis of DVT following cancer surgery A double-blind, multicenter trial, compared a four-week and a one-week regimen of enoxaparin sodium prophylaxis in terms of safety and efficacy in 332 patients undergoing elective surgery for abdominal or pelvic cancer.
Danish: • Forlænget DVT-profylakse efter cancerkirurgi Et dobbeltblindt multicenterstudie sammenlignede fire ugers behandling og en uges behandling med enoxaparinnatrium-profylakse med hensyn til sikkerhed og virkning hos 332 patienter, der fik foretaget planlagt kirurgi for abdominal- eller bækkencancer.
English: The enoxaparin sodium dosing strategy was adjusted for severe renally impaired patients and for the elderly of at least 75 years of age.
Danish: Dosis af enoxaparinnatrium blev justeret hos patienter med svært nedsat nyrefunktion og hos ældre patienter over 75 år.
English: This will send the medicine into the fatty tissue of the stomach.
Danish: Herved sprøjtes lægemidlet ind i mavens fedtvæv.
English: Renal clearance of active fragments represents about 10% of the administered dose and total renal excretion of active and non-active fragments 40% of the dose.
Danish: Ca. 10 % af den administrerede dosis udskilles som aktive metabolitter renalt, og totalt udskilles 40 % af dosis renalt som aktive og ikke-aktive metabolitter.
English: • Rare: Cases of immuno-allergic thrombocytopenia with thrombosis; in some of them thrombosis was complicated by organ infarction or limb ischaemia (see section 4.4).
Danish: • Sjælden: Tilfælde af immun-allergisk trombocytopeni med trombose; i nogle af tilfældene blev trombose kompliceret af organinfarkt eller iskæmi i ekstremitet (se pkt.
English: Start taking the direct oral anticoagulant 0-2 hours before the time you would have had the next injection, then continue as normal.
Danish: Du skal begynde at tage den direkte orale antikoagulans 0-2 timer før, du skulle have haft den næste indsprøjtning.
English: • General
Danish: • Generelt
English: Thorinane can be used during breastfeeding.
Danish: Thorinane kan anvendes i ammeperioden.
English: • SC injection technique:
Danish: • Subkutan injektionsteknik:
English: Anti-Xa levels are still detectable at these time points, and these delays are not a guarantee that neuraxial hematoma will be avoided.
Danish: Anti-Xa-niveau er stadig detekterbart på disse tidspunkter, og udsat anlæggelse eller fjernelse af et kateter er ikke garanti for, at der ikke forekommer neuraksialt hæmatom.
English: Required dose 30 IU/kg (0.3 mg/kg)
Danish: Ønsket dosis 30 IE/kg (0,3 mg/kg)
English: If a manual compression method is used, sheath should be removed 6 hours after the last IV/SC enoxaparin sodium injection.
Danish: Hvis en manuel kompressionsmetode anvendes, skal sheathen fjernes 6 timer efter den sidste intravenøse/subkutane injektion af enoxaparinnatrium.
English: • Spinal or epidural anaesthesia or loco-regional anaesthesia when enoxaparin sodium is used for treatment in the previous 24 hours (see section 4.4).
Danish: • Spinal- eller epiduralanæstesi eller lokal/regional anæstesi, når enoxaparinnatrium er blevet anvendt til behandling inden for de forudgående 24 timer (se pkt.
English: 9) Drop the used syringe with its protective sleeve into the sharps bin provided.
Danish: 9) Læg den brugte sprøjte med nålebeskyttelsen ned i en speciel beholder til skarpe genstande.
English: 4,716 patients underwent percutaneous coronary intervention receiving antithrombotic support with blinded study drug.
Danish: 4.716 patienter gennemgik perkutan koronar angioplastik og fik antitrombotika med det blindede studielægemiddel.
English: Stopping blood clots forming in your blood in the following situations: Operation or periods of limited mobility due to an illness
Danish: Til forebyggelse af blodpropper i følgende situationer: Operation eller perioder med sengeleje/begrænset bevægelighed på grund af sygdom
English: Besides the anticoagulant effects of enoxaparin sodium, there was no evidence of adverse effects at 15 mg/kg/day in the 13-week SC toxicity studies both in rats and dogs and at 10 mg/kg/day in the 26-week SC and IV toxicity studies both in rats, and monkeys.
Danish: Udover enoxaparinnatriums antikoagulerende virkninger var der ikke evidens for negative virkninger ved 15 mg/kg/dag subkutant i 13 uger lange toksicitetsstudier hos rotter og hunde eller i 26 uger lange toksicitetsstudier hos rotter og aber ved 10 mg/kg/dag subkutant og intravenøst.
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 - åndenød, smerter i brystkassen, besvimelse eller ophostning af blod - dette er symptomer på
English: The dose regimen of 100 IU/kg (1 mg/kg) administered twice daily should be used in all other patients such as those with obesity, with symptomatic PE, cancer, recurrent VTE or proximal (vena iliaca) thrombosis.
Danish: Dosisregimet på 100 IE/kg (1 mg/kg) to gange dagligt skal anvendes hos alle andre patienter som f.eks. svært overvægtige patienter, patienter med symptomatisk PE, cancer, tilbagevendende VTE eller proksimal (vena iliaca) trombose.
English: • Aspirin (also known as acetylsalicylic acid or ASA), clopidogrel or other medicines used to stop blood clots from forming (see also in section 3, “Changing of anticoagulant medicine”)
Danish: • Acetylsalicylsyre, clopidogrel eller andre lægemidler, der bruges til at forhindre dannelse af blodpropper (se også punkt 3, ”Skift mellem blodfortyndende medicin”)
English: Do not use Thorinane
Danish: Brug ikke Thorinane:
English: For acute STEMI, treatment is to be initiated with a single IV bolus injection immediately followed by a SC injection.
Danish: Ved akut STEMI indledes behandlingen med en enkelt intravenøs bolusinjektion umiddelbart efterfulgt af en subkutan injektion.
English: What Thorinane contains - The active substance is enoxaparin sodium.
Danish: Thorinane indeholder - Aktivt stof: enoxaparinnatrium.
English: What you need to know before you use Thorinane
Danish: Det skal du vide, før du begynder at bruge Thorinane
English: Having this medicine
Danish: Sådan får du lægemidlet
English: Make sure you hold the skin fold throughout the injection.
Danish: Sørg for at holde hudfolden sammenklemt under hele indsprøjtningen.
English: SC injection Do not mix with other products.
Danish: Subkutan injektion Dette lægemiddel må ikke blandes med andre lægemidler.
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: 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 continuous techniques, a similar delay of at least 12 hours should be observed before removing the catheter.
Danish: Ved fortsat behandling skal der være et lignende interval på mindst 12 timer, før kateteret fjernes.
English: If such use is considered absolutely necessary, the decision must be made only after a careful individual benefit risk assessment.
Danish: Hvis behandling med heparin anses for absolut nødvendig, skal beslutningen være baseret på en omhyggelig benefit/risk-vurdering hos den enkelte patient.
English: Enoxaparin sodium was found to have no effect on fertility or reproductive performance of male and female rats at SC doses up to 20 mg/kg/day.
Danish: Det er påvist, at enoxaparinnatrium ikke påvirker fertiliteten eller reproduktionsevnen hos han- og hunrotter ved subkutane doser på op til 20 mg/kg/dag.
English: The amount will depend on the reason it is being used.
Danish: Den mængde, du får, afhænger af,
English: • An initial dose of 3,000 IU (30 mg) of Thorinane will be given as injection into your vein.
Danish: • Du får en startdosis på 3.000 IE (30 mg) Thorinane som en indsprøjtning i en vene.
English: For the initial 3,000 IU (30 mg) bolus, using an enoxaparin sodium graduated pre-filled syringe, expel the excessive volume to retain only 3,000 IU (30 mg) in the syringe.
Danish: Til den initiale 3.000 IE (30 mg) bolus anvendes en gradueret fyldt injektionssprøjte med enoxaparinnatrium, og den overskydende volumen presses ud, så der kun er 3.000 IE (30 mg) tilbage i sprøjten.
English: The following medicinal products may be administered with caution concomitantly with enoxaparin sodium:
Danish: Samtidig anvendelse kan ske med forsigtighed: Følgende lægemidler kan med forsigtighed administreres samtidigt med enoxaparinnatrium:
English: Thorinane should not be used interchangeably with other medicines belonging to the group of low molecular weight heparins.
Danish: Thorinane bør ikke umiddelbart udskiftes med anden medicin, der tilhører gruppen af lavmolekylære hepariner.
English: These events are rare with enoxaparin sodium dosage regimens 4,000 IU (40 mg) once daily or lower.
Danish: Disse tilfælde er sjældne ved enoxaparinnatrium-doser på 4.000 IE (40 mg) en gang dagligt eller lavere.
English: • Common: Haemorrhage, haemorrhagic anaemia*, thrombocytopenia, thrombocytosis
Danish: • Almindelig: Blødning, hæmoragisk anæmi*, trombocytopeni, trombocytose
English: As with other anticoagulants, haemorrhage may occur in the presence of associated risk factors such as: organic lesions liable to bleed, invasive procedures or the concomitant use of medications affecting haemostasis (see sections 4.4 and 4.5).
Danish: Som med andre antikoagulantia kan der forekomme blødning ved tilstedeværelse af tilknyttede risikofaktorer såsom organiske læsioner, der er tilbøjelige til at bløde, invasive indgreb eller samtidig brug af lægemidler, der påvirker hæmostasen (se pkt.
English: There was a higher incidence of gastrointestinal bleeding in the enoxaparin sodium group (0.5%) versus the heparin group (0.1%), while the incidence of intracranial haemorrhage was similar in both groups (0.8% with enoxaparin sodium versus 0.7% with heparin).
Danish: Der var en højere forekomst af gastrointestinal blødning i enoxaparinnatrium-gruppen (0,5 %) versus heparin-gruppen (0,1 %), mens forekomsten af intrakranial blødning var sammenlignelig i de to grupper (0,8 % med enoxaparinnatrium versus 0,7 % med heparin).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: • Pregnant women with mechanical prosthetic heart valves
Danish: • Gravide kvinder med hjerteklapprotese
English: Each mL contains 100 mg enoxaparin sodium.
Danish: Hver ml indeholder 100 mg enoxaparinnatrium.
English: 1) Wash your hands and the area that you will inject with soap and water.
Danish: Vejledning i at give dig selv en indsprøjtning med Thorinane 1) Vask hænderne og det område, hvor du vil give indsprøjtningen, med sæbe og vand.
English: Enoxaparin sodium is to be used with extreme caution in patients with a history (>100 days) of heparininduced thrombocytopenia without circulating antibodies.
Danish: Enoxaparinnatrium skal anvendes med ekstrem forsigtighed hos patienter med heparin-induceret trombocytopeni i anamnesen (>100 dage) uden cirkulerende antistoffer.
English: Very common: Haemorrhage α
Danish: Meget almindelig: Blødning α
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 heparin-induceret trombocytopeni (HIT) inden for de seneste 100 dage eller ved tilstedeværelse af cirkulerende antistoffer (se også pkt.
English: Treatment in patients with unstable angina and non-Q-wave MI
Danish: Behandling af patienter med ustabil angina pectoris og MI uden Qtaksudvikling
English: In the in vitro purified system, enoxaparin sodium has a high anti-Xa activity (approximately 100 IU/mg) and low anti-IIa or anti thrombin activity (approximately 28 IU/mg), with a ratio of 3.6.
Danish: In vitro har oprenset enoxaparinnatrium en høj anti-Xa-aktivitet (ca. 100 IE/mg) og en lav anti-IIaeller antitrombin-aktivitet (ca. 28 IE/mg) med en ratio på 3,6.
English: When used as prophylactic treatment, enoxaparin sodium does not significantly affect the aPTT.
Danish: Når enoxaparinnatrium anvendes som profylaktisk behandling, påvirker det ikke aPTT i signifikant grad.
English: • Rare: Eosinophilia*
Danish: • Sjælden: Eosinofili*
English: • Bruising or pain at the injection site.
Danish: • Blå mærker eller smerter på injektionsstedet.
English: 2) Stopping blood clots from forming in your blood.
Danish: 2) Det forhindrer, at der dannes blodpropper i blodet.
English: For patients currently receiving a DOAC, the first dose of enoxaparin sodium should be given at the time the next DOAC dose would be taken.
Danish: Hos patienter i behandling med DOAK skal den første dosis enoxaparinnatrium gives på det tidspunkt, hvor den næste DOAK-dosis skulle tages.
English: Enoxaparin sodium is not recommended for patients with end stage renal disease (creatinine clearance <15 mL/min) due to lack of data in this population outside the prevention of thrombus formation in extra corporeal circulation during haemodialysis.
Danish: Enoxaparinnatrium bør ikke anvendes hos patienter med nyresygdom i slutstadiet (kreatinin-clearance <15 ml/min) på grund af manglende data for denne population, undtagen ved profylakse mod trombose i det ekstrakorporale kredsløb under dialyse.
English: • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery.
Danish: • Behandling af dyb venetrombose (DVT) og lungeemboli (PE) med undtagelse af PE, hvor trombolytisk behandling eller operation sandsynligvis er nødvendigt.
English: Administration in spinal/epidural anaesthesia or lumbar puncture Should the physician decide to administer anticoagulation in the context of epidural or spinal anaesthesia/analgesia or lumbar puncture, careful neurological monitoring is recommended due to the risk of neuraxial haematomas (see section 4.4).
Danish: Administration ved spinal-/epiduralanæstesi eller lumbalpunktur Hvis lægen beslutter at administrere et antikoagulans i forbindelse med spinal- eller epiduralanæstesi/analgesi eller lumbalpunktur, anbefales tæt neurologisk monitorering på grund af risikoen for neuraksialt hæmatom (se pkt.
English: Common: Haemorrhage α
Danish: Almindelig: Blødning α
English: • Uncommon: Hepatocellular liver injury *
Danish: • Ikke almindelig: Hepatocellulær leverskade*
English: Supplied in packs of 2 or 10 pre-filled syringes.
Danish: Pakninger med 2 eller 10 fyldte sprøjter.
English: o For patients managed with PCI, if the last dose of enoxaparin sodium SC was given less than 8 hours before balloon inflation, no additional dosing is needed.
Danish: o Patienter, der har undergået PCI: Hvis den sidste subkutane dosis enoxaparinnatrium blev givet mindre end 8 timer før ballonudvidelsen, er en yderligere dosis ikke nødvendig.
English: The incidence of major bleeding at 30 days was significantly higher (p<0.0001) in the enoxaparin sodium group (2.1%) versus the heparin group (1.4%).
Danish: Forekomsten af alvorlig blødning i løbet af 30 dage var signifikant højere (p<0,0001) i enoxaparinnatrium-gruppen (2,1 %) versus heparin-gruppen (1,4 %).
English: - Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac, - Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants (see section 4.2).
Danish: Disse lægemidler omfatter: - Systemiske salicylater, acetylsalicylsyre i antiinflammatoriske doser og NSAID'er, herunder ketorolac, - Andre trombolytika (f.eks. alteplase, reteplase, streptokinase, tenecteplase, urokinase) og antikoagulantia (se pkt.
English: If you are pregnant and have a mechanical heart valve, you may be at an increased risk of developing blood clots.
Danish: Du må ikke få lægemidlet, hvis du er gravid og har en mekanisk hjerteklap, da du kan have en større risiko for at få blodpropper.
English: 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: If you forget to use Thorinane
Danish: Hvis du har glemt at tage Thorinane
English: After you have had a heart attack
Danish: • hvis du har fået indsat en hjerteklap
English: Do not give yourself a double dose on the same day to make up for a forgotten dose.
Danish: 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: This could be because of a blood problem with low platelet counts.
Danish: Dette kan skyldes, at du har for få blodplader.
English: The occurrence of total and major bleeding were respectively 8.6% and 1.1% in the placebo group, 11.7% and 0.3% in the enoxaparin sodium 2,000 IU (20 mg) group and 12.6% and 1.7% in the enoxaparin sodium 4,000 IU (40 mg) group.
Danish: Den samlede forekomst af blødning og af alvorlig blødning var henholdsvis 8,6 % og 1,1 % i placebogruppen, 11,7 % og 0,3 % i gruppen, der fik enoxaparinnatrium 2.000 IE (20 mg), og 12,6 % og 1,7 % i gruppen, der fik enoxaparinnatrium 4.000 IE (40 mg).