FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine should be injected just under the skin on your stomach, but not too near the belly button or any scar tissue (at least 5 cm away from these).
Danish: Lægemidlet skal indsprøjtes lige under huden på maven, men ikke for tæt på navlen eller eventuelt arvæv (mindst 5 cm væk fra begge dele).
English: 7) Press down on the plunger with your finger.
Danish: 7) Tryk stemplet ned med fingeren.
English: • If you are allergic to heparin or other low molecular weight heparins such as nadroparin, tinzaparin or dalteparin.
Danish: • Hvis du er allergisk over for heparin eller andre lavmolekylære hepariner som f.eks. nadroparin, tinzaparin eller dalteparin.
English: This could be a sign of bleeding in the brain.
Danish: Dette kan være tegn på en hjerneblødning.
English: This is because it needs to be given as an injection.
Danish: Det skyldes, at det skal gives som en
English: The anticoagulant effects can be largely neutralized by the slow IV injection of protamine.
Danish: Den antikoagulerende virkning kan i stort omfang neutraliseres ved langsom intravenøs injektion af protamin.
English: 8) Remove the needle by pulling it straight out.
Danish: 8) Fjern nålen ved at trække sprøjten lige ud.
English: • Very common: Hepatic enzyme increases (mainly transaminases > 3 times the upper limit of normality)
Danish: • Meget almindelig: Forhøjede leverenzymer (hovedsageligt aminotransferaser > 3 gange normal øvre grænse)
English: The oral absorption of enoxaparin sodium is unlikely.
Danish: Oral absorption af enoxaparin er usandsynlig.
English: • you have endocarditis (an infection of the inner lining of the heart)
Danish: • hvis du har endocarditis (en infektion i den hinde, der dækker hjertets inderside)
English: For treatment of acute STEMI in elderly patients ≥75 years of age, an initial IV bolus must not be used.
Danish: Ved behandling af akut STEMI hos ældre patienter ≥ 75 år må der ikke gives initial intravenøs bolus.
English: Do not inject Thorinane into a muscle.
Danish: Thorinane må ikke sprøjtes ind i en muskel.
English: It is not known whether unchanged enoxaparin is excreted in human breast milk.
Danish: Det vides ikke, om uomdannet enoxaparin udskilles i human mælk.
English: Instruct patients to report immediately if they experience any of the above signs or symptoms.
Danish: Patienterne skal informeres om straks at kontakte lægen, hvis de får et eller flere af ovenstående symptomer.
English: Extracorporeal use (in the dialysis circuit).
Danish: Ekstrakorporal anvendelse (i dialysekredsløbet).
English: • The maximum amount of Thorinane given for the first two injections is 7,500 IU (75 mg).
Danish: • Den højeste dosis Thorinane, der gives i de to første indsprøjtninger, er 7.500 IE (75 mg).
English: Note for the pre-filled syringes fitted with an automatic safety system: The safety system is triggered at the end of the injection (see instructions in section 6.6).
Danish: For de fyldte injektionssprøjter, der er forsynet med et automatisk sikkerhedssystem: Bemærk at sikkerhedssystemet udløses ved slutningen af injektionen (se instruktioner i pkt.
English: These patients should be observed carefully for signs and symptoms of thromboembolism.
Danish: Disse patienter bør observeres nøje for symptomer på tromboemboli.
English: These anticoagulant activities are mediated through anti-thrombin III (ATIII) resulting in anti-thrombotic activities in humans.
Danish: Disse antikoagulerende aktiviteter medieres af antitrombin III (ATIII), hvilket resulterer i antitrombotisk virkning hos mennesker.
English: This difference persisted at three months [13.8% vs. 5.5% (n=23 vs 9), p=0.01].
Danish: Denne forskel var opretholdt efter tre måneder [13,8 % versus 5,5 % (n=23 versus 9), p=0,01].
English: The safety and efficacy of prophylactic doses in obese patients (BMI >30 kg/m2) has not been fully determined and there is no consensus for dose adjustment.
Danish: Sikkerheden og virkningen af profylaktiske doser hos svært overvægtige patienter (BMI > 30 kg/m2) er ikke helt fastlagt, og der er ikke konsensus for dosisjustering.
English: • Rare: Alopecia*
Danish: • Sjælden: Alopeci*
English: Treatment in patients with acute STEMI
Danish: Behandling af patienter med akut STEMI
English: If you think that you have used too much or too little Thorinane, tell your doctor, nurse or pharmacist immediately, even if you have no signs of a problem.
Danish: Hvis du tror, at du har taget for meget eller for lidt Thorinane, skal du straks fortælle det til lægen, sundhedspersonalet eller apotekspersonalet, også selvom du ikke har tegn på, at det er et problem.
English: Other adverse reactions observed in clinical studies and reported in post-marketing experience (* indicates reactions from post-marketing experience) are detailed below.
Danish: Andre bivirkninger, der blev observeret i kliniske studier eller indberettet efter markedsføringen (* betegner bivirkninger indberettet efter markedsføring), er anført nedenfor.
English: • If you have problems with your kidneys you may be given a smaller amount of Thorinane.
Danish: • Hvis du har problemer med nyrerne, vil du muligvis få en mindre dosis Thorinane.
English: Bilateral venography was performed between days 25 and 31, or sooner if symptoms of venous thromboembolism occurred.
Danish: Der blev foretaget bilateral flebografi mellem dag 25 og dag 31 eller tidligere, hvis der opstod symptomer på venøs tromboemboli.
English: Patients must be aware that these symptoms may occur and if so, that they should inform their primary care physician.
Danish: Patienten skal informeres om, at disse symptomer kan opstå, og at patienten, i givet fald, skal fortælle det til egen læge.
English: This should be at least 5 cm away from your belly button and out towards your sides.
Danish: Det skal være mindst 5 cm fra din navle og ud mod siden.
English: VTE = Venous thromboembolic events which included DVT, PE, and death considered to be thromboembolic in origin * p value versus placebo =0.0002
Danish: VTE = Venetromboemboliske hændelser, som omfattede DVT, PE og død, der anses for at være et resultat af tromboembolisk sygdom * p-værdi versus placebo =0,0002
English: The risk of HIT is higher in postoperative patients and mainly after cardiac surgery and in patients with cancer.
Danish: Risikoen for HIT er øget hos postoperative patienter og især efter hjertekirurgi og hos cancerpatienter.
English: Animal data have shown that enoxaparin passage through the placenta is minimal.
Danish: Dyrestudier har vist, at enoxaparins passage over placenta er minimal.
English: • Pink patches on your skin.
Danish: • Lyserøde områder på huden.
English: If you stop, you could get a blood clot which can be very dangerous .
Danish: Hvis du stopper med at bruge det, kan du få en blodprop, hvilket kan være meget farligt.
English: Treatment should be maintained for a minimum of 2 days and continued until clinical stabilization.
Danish: Behandlingen bør gives i mindst 2 dage og fortsætte, indtil patienten er stabiliseret klinisk.
English: • Your doctor will normally ask you to take aspirin (acetylsalicylic acid) as well.
Danish: • Normalt vil lægen anbefale, at du også får acetylsalicylsyre.
English: • Large red irregularly shaped skin lesions with or without blisters.
Danish: • Store, røde, uregelmæssige hudskader med eller uden blærer.
English: • Dextran injection - used as a blood replacer
Danish: • Dextran-indsprøjtning - bruges som erstatning for blod
English: At higher doses, increases in activated partial thromboplastin time (aPTT), and activated clotting time (ACT) may occur.
Danish: Ved højere doser kan der forekomme forlængelse af aktiveret partiel tromboplastintid (aPTT) og aktiveret koagulationstid (ACT).
English: The site of the procedure should be observed for signs of bleeding or hematoma formation.
Danish: Operationsstedet skal observeres for tegn på blødning eller hæmatomdannelse.
English: If the combination is indicated, enoxaparin sodium should be used with careful clinical and laboratory monitoring when appropriate.
Danish: Hvis kombinationen er indiceret, bør enoxaparinnatrium anvendes under omhyggelig klinisk og laboratoriemæssig overvågning, når det er hensigtsmæssigt.
English: • Rare: Cutaneous vasculitis*, skin necrosis* usually occurring at the injection site (these phenomena have been usually preceded by purpura or erythematous plaques, infiltrated and painful).
Danish: • Sjælden: Kutan vaskulitis*, hudnekrose*, der sædvanligvis forekommer på injektionsstedet (disse fænomener forudgås normalt af purpura eller erytematøs plaque, infiltreret og smertefuld).
English: • Switch between enoxaparin sodium and vitamin K antagonists (VKA) Clinical monitoring and laboratory tests [prothrombin time expressed as the International Normalized Ratio (INR)] must be intensified to monitor the effect of VKA.
Danish: • Skift mellem enoxaparinnatrium og vitamin K-antagonister (VKA) Klinisk monitorering og laboratorieprøver [protrombintid udtrykt som International Normaliseret Ratio (INR)] skal intensiveres for at monitorere virkningen af VKA.
English: In case of self-administration, patient should be advised to follow instructions provided in the patient information leaflet included in the pack of this medicine.
Danish: Ved selvadministration skal tilrådes patienten at følge anvisningerne i indlægssedlen, som ligger i pakningen sammen med lægemidlet.
English: o Initial 3,000 IU (30 mg) bolus
Danish: o Indledende 3.000 IE (30 mg) bolus
English: Pre-filled syringe 2 years
Danish: Fyldt sprøjte 2 år
English: Elimination appears monophasic with a half-life of about 5 hours after a single SC dose to about 7 hours after repeated dosing.
Danish: Eliminationen synes at være monofasisk med en halveringstid på ca. 5 timer efter en enkelt subkutan dosis til ca. 7 timer efter gentagen dosering.
English: Thorinane can be used to:
Danish: Thorinane kan anvendes til:
English: In some cases the bleeding may not be obvious.
Danish: Sådanne blødninger er ikke altid synlige.
English: NSTEMI type of heart attack:
Danish: Hjerteanfald af typen NSTEMI:
English: This can lead to a loss of the medicine.
Danish: Noget af lægemidlet kan gå tabt.
English: Injection volume and dose concentration over the range 100-200 mg/mL does not affect pharmacokinetic parameters in healthy volunteers.
Danish: Injektionsvolumen og dosiskoncentration i intervallet 100-200 mg/ml påvirker ikke de farmakokinetiske parametre hos raske forsøgspersoner.
English: Likewise, consider not using enoxaparin sodium until at least 4 hours after the spinal/epidural puncture or after the catheter has been removed.
Danish: På samme måde bør det overvejes ikke at anvende enoxaparinnatrium før mindst 4 timer efter spinal/epiduralpunktur eller efter fjernelse af kateteret.
English: The delay must be based on a benefit-risk assessment considering both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors.
Danish: Udsættelsen skal baseres på en benefit/riskvurdering, hvor både risikoen for trombose og risikoen for blødning under proceduren og patientens risikofaktorer tages i betragtning.
English: The efficacy data are provided in the table below.
Danish: Effektdata er vist i nedenstående tabel.
English: These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and anti-IIa activities, units, dosage and clinical efficacy and safety.
Danish: Disse lægemidler er forskellige for så vidt angår fremstillingsproces, molekylvægt, specifik anti-Xa- og antiIIa-aktivitet, enheder, dosering og klinisk virkning og sikkerhed.
English: 6) Hold the syringe so that the needle is pointing downwards (vertically at a 90º angle).
Danish: 6) Hold sprøjten sådan, at nålen peger nedad (lodret i en vinkel på 90º).
English: Enoxaparin sodium regimen administered during these clinical trials varies depending on indications.
Danish: Doseringsregimet af enoxaparinnatrium administreret i disse kliniske studier varierede afhængigt af indikationen.
English: Subcutaneous, intravenous use.
Danish: Subkutan/intravenøs anvendelse.
English: The whole length of the needle should be introduced vertically into a skin fold gently held between the thumb and index finger.
Danish: Nålens fulde længde skal indføres vertikalt i en hudfold, som holdes mellem tommel- og pegefinger.
English: The recommended duration of treatment is 8 days or until hospital discharge, whichever comes first.
Danish: Den anbefalede behandlingsvarighed er 8 dage, eller indtil patienten udskrives fra hospitalet afhængigt af, hvad der forekommer først.
English: You may have bleeding in your stomach.
Danish: Dette kan være en indre blødning i maven.
English: These included major haemorrhages, reported at most in 4.2 % of the patients (surgical patients).
Danish: Blødning inkluderer alvorlige blødninger, der blev rapporteret hos højst 4,2 % af patienterne (kirurgiske patienter).
English: Therefore, it is recommended that the platelet counts be measured before the initiation of therapy with enoxaparin sodium and then regularly thereafter during the treatment.
Danish: Det anbefales derfor, at trombocyttallet måles inden behandlingsstart med enoxaparinnatrium og regelmæssigt under behandlingen.
English: Based on the results of a population pharmacokinetic analysis, the enoxaparin sodium kinetic profile is not different in elderly subjects compared to younger subjects when renal function is normal.
Danish: Baseret på resultaterne fra en populationsfarmakokinetisk analyse er enoxaparinnatriums kinetiske profil ikke anderledes hos ældre personer med normal nyrefunktion sammenlignet med yngre personer.
English: • Rare: Spinal haematoma* (or neuraxial haematoma).
Danish: • Sjælden: Spinalt hæmatom* (eller neuraksialt hæmatom).
English: These are more likely to appear in the area you have been injected with Thorinane.
Danish: Dette ses oftest i det område, hvor Thorinane er blevet sprøjtet
English: No increased bleeding tendency is observed in the elderly with the prophylactic dosage ranges.
Danish: Der ses ingen øget blødningstendens hos ældre inden for de profylaktiske dosisintervaller.
English: • Uncommon: Bullous dermatitis
Danish: • Ikke almindelig: Bulløs dermatitis
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF
English: The skin fold should not be released until the injection is complete.
Danish: Hudfolden må ikke slippes, før injektionen er fuldført.
English: 1) Stopping existing blood clots from getting any bigger.
Danish: 1) Det forhindrer eksisterende blodpropper i at blive større.
English: The quantitative determination of anti-Xa and anti-IIa pharmacokinetic activities was conducted by validated amidolytic methods.
Danish: Kvantificering af den farmakokinetiske aktivitet af anti-Xa og anti-IIa blev udført med validerede amidolytiske metoder.
English: In lactating rats, the passage of enoxaparin or its metabolites in milk is very low.
Danish: Hos diegivende rotter er koncentrationen af enoxaparin og dets metabolitter i mælken meget lav.
English: Pregnant women receiving enoxaparin sodium should be carefully monitored for evidence of bleeding or excessive anticoagulation and should be warned of the haemorrhagic risk.
Danish: Gravide kvinder, der får enoxaparinnatrium, bør monitoreres tæt for tegn på blødning eller overdreven antikoagulation og bør advares om risikoen for blødning.
English: Oral anticoagulant therapy should be initiated when appropriate (see “Switch between enoxaparin sodium and oral anticoagulants” at the end of section 4.2).
Danish: Behandling med oral antikoagulans bør initieres, når det er hensigtsmæssigt (se ”Skift mellem enoxaparinnatrium og orale antikoagulantia” i slutningen af pkt.
English: As there is an interval before the VKA reaches its maximum effect, enoxaparin sodium therapy should be continued at a constant dose for as long as necessary in order to maintain the INR within the desired therapeutic range for the indication in two successive tests.
Danish: Eftersom VKA først når deres maksimale virkning efter nogen tid, bør enoxaparinnatriumbehandlingen fortsættes ved en konstant dosis så længe, som det er nødvendigt for at fastholde INR inden for det ønskede terapeutiske område for indikationen i to på hinanden følgende prøver.
English: Enoxaparin sodium treatment is prescribed for an average period of 10 days.
Danish: Behandling med enoxaparinnatrium ordineres gennemsnitligt i 10 dage.
English: If the treatment with enoxaparin sodium is to be continued, the next scheduled dose should be given no sooner than 6 to 8 hours after sheath removal.
Danish: Hvis behandling med enoxaparinnatrium skal fortsætte, må næste planlagte dosis ikke gives tidligere end 6 til 8 timer efter fjernelse af sheathen.
English: Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11 1077XX Amsterdam Netherlands
Danish: Strawinskylaan 1143, Toren C-11 1077XX Amsterdam Holland
English: A lounge chair, recliner, or bed propped up with pillows is ideal.
Danish: En behagelig stol, lænestol eller en seng, hvor du kan sidde op ad puder, er ideelt.
English: The administration should be alternated between the left and right anterolateral or posterolateral abdominal wall.
Danish: Injektionen skal gives skiftevis i venstre og højre anterolaterale eller posterolaterale abdominalvæg.
English: Appropriate antiplatelet therapy such as oral acetylsalicylic acid (75 mg to 325 mg once daily) should be administered concomitantly unless contraindicated.
Danish: Passende trombocythæmmende behandling som f.eks. oral acetylsalicylsyre (75 mg til 325 mg en gang dagligt) bør administreres samtidigt, medmindre der er kontraindikationer.
English: Switch between enoxaparin sodium and oral anticoagulants
Danish: Skift mellem enoxaparinnatrium og orale antikoagulantia
English: • If you have had a reaction to heparin that caused a severe drop in the number of your clotting cells (platelets) - this reaction is called heparin-induced thrombocytopenia - within the last 100 days or if you have antibodies against enoxaparin in your blood.
Danish: • Hvis du haft en allergisk reaktion over for heparin, som medførte et alvorligt fald i antallet af de celler, der får blodet til at størkne (blodplader) (denne reaktion kaldes heparininduceret trombocytopeni) inden for de seneste 100 dage, eller hvis du har antistoffer mod enoxaparin i blodet.
English: • you have high level of potassium in your blood (this may be checked with a blood test)
Danish: • hvis du har et højt indhold af kalium i blodet (kan ses i en blodprøve)
English: Overall, the data suggest that there is no evidence for an increased risk of haemorrhage, thrombocytopenia or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves (see section 4.4).
Danish: Overordnet set antyder data, at der ikke er en øget risiko for blødning, trombocytopeni eller osteoporose sammenlignet med den observerede risiko hos ikke-gravide kvinder, på nær den øgede risiko hos gravide kvinder med hjerteklapprotese (se pkt.
English: • Rare: Anaphylactic/Anaphylactoid reactions including shock*
Danish: • Sjælden: Anafylaktiske/anafylaktoide reaktioner inklusive shock*
English: Use of heparin is usually not recommended in patients with acute infective endocarditis due to the risk of cerebral haemorrhage.
Danish: Anvendelse af heparin anbefales sædvanligvis ikke til patienter med akut infektiøs endocarditis på grund af risikoen for cerebral blødning.
English: The decision to use enoxaparin sodium in such a case must be made only after a careful benefit risk assessment and after non-heparin alternative treatments are considered (e.g. danaparoid sodium or lepirudin).
Danish: Beslutningen om at anvende enoxaparinnatrium i sådanne tilfælde må kun træffes efter en omhyggelig benefit/risk-vurdering og efter at have overvejet anden behandling uden heparin (f.eks. danaparoidnatrium eller lepirudin).
English: Enoxaparin sodium has been evaluated in more than 15,000 patients who received enoxaparin sodium in clinical trials.
Danish: Enoxaparinnatrium blev evalueret hos flere end 15.000 patienter, der fik enoxaparinnatrium i kliniske studier.
English: - enoxaparin sodium every 12 hours versus heparin (-4.2 to 1.7).
Danish: - enoxaparinnatrium hver 12. time versus heparin (-4,2 til 1,7).
English: - Check the syringe is not damaged and the medicine in it is a clear solution.
Danish: - Undersøg sprøjten for at kontrollere, at den ikke er beskadiget, og at lægemidlet i sprøjten er en klar væske.
English: Musculoskeletal, connective tissue and bone disorders • Rare: Osteoporosis* following long term therapy (greater than 3 months)
Danish: Knogler, led, muskler og bindevæv • Sjælden: Osteoporose* efter langvarig behandling (længere end 3 måneder)
English: Enoxaparin sodium or standard heparin therapy was administered for a minimum of 5 days and until the targeted warfarin sodium INR was achieved.
Danish: Enoxaparinnatrium eller standard-heparin blev administreret i mindst 5 dage, og indtil det tilsigtede INR for warfarinnatrium blev nået.
English: This decrease was mainly attributed to a decrease in ATIII level secondary to a reduced synthesis of ATIII in patients with hepatic impairment.
Danish: Reduktionen skyldtes hovedsageligt et mindsket ATIII-niveau som følge af nedsat ATIII-syntese hos patienter med nedsat leverfunktion.
English: 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: Lægen bør vælge behandling ud fra en individuel vurdering, herunder evaluering af risikoen for tromboemboli og blødning.
English: Both enoxaparin sodium regimens were equivalent to standard heparin therapy in reducing the risk of recurrent venous thromboembolism (DVT and/or PE).
Danish: Begge enoxaparinnatrium-behandlinger var ækvivalente med behandling med standardheparin med hensyn til at reducere risikoen for recidiverende venøs tromboemboli (DVT og/eller PE).
English: Animal studies did not show any effect on fertility (see section 5.3).
Danish: Dyrestudier viser ingen indvirkning på fertilitet (se pkt.
English: This amount is usually enough for a 4-hour session.
Danish: Denne mængde er sædvanligvis nok til en dialysebehandling på 4 timer.
English: STEMI type of heart attack if you are under 75 years old:
Danish: Hjerteanfald af typen STEMI, hvis du er under 75 år:
English: Nervous system disorders • Common: Headache*
Danish: Nervesystemet • Almindelig: Hovedpine*
English: There were no significant differences in major haemorrhages, although a haemorrhage at the site of the SC injection was more frequent.
Danish: Der var ingen signifikante forskelle i alvorlige blødningsepisoder, selvom blødning omkring det subkutane injektionssted var mere hyppigt forekommende.
English: • Ibuprofen, diclofenac, ketorolac or other medicines known as non-steroidal anti-inflammatory agents which are used to treat pain and swelling in arthritis and other conditions
Danish: • Ibuprofen, diclofenac, ketorolac og andre lægemidler kendt som non-steroide antiinflammatoriske stoffer, som anvendes til behandling af smerter og hævelse i forbindelse med gigt og andre sygdomme
English: When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific), enoxaparin sodium should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy.
Danish: Ved administration i kombination med et trombolytikum (fibrinspecifikt eller ikke-fibrinspecifikt) skal enoxaparinnatrium gives mellem 15 minutter før og 30 minutter efter opstart af fibrinolytisk behandling.
English: Dose adjustment based on monitoring of anti-Xa levels is unreliable in patients with liver cirrhosis and not recommended (see section 5.2).
Danish: Dosisjustering baseret på monitorering af anti-Xa-niveau er upålidelig hos patienter med levercirrose og anbefales ikke (se pkt.
English: There are no clinical data for enoxaparin sodium in fertility.
Danish: Der foreligger ingen kliniske data for enoxaparinnatrium vedrørende fertilitet.