FrancophonIA/ELRC3.0 huggingface dataset:
English: Change the place where you inject each time from the right to the left side of your stomach.
Danish: Skift indsprøjtningssted hver gang fra højre til venstre side af maven.
English: Use in children and adolescents The safety and efficacy of Thorinane has not been evaluated in children or adolescents.
Danish: Brug til børn og unge THORINANE' (og relaterede navne) sikkerhed og virkning er ikke undersøgt hos børn og unge.
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 Thorinane.
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 Thorinane.
English: For all indications except STEMI, no dose reduction is necessary in the elderly patients, unless kidney function is impaired (see below “renal impairment” and section 4.4).
Danish: For alle indikationer med undtagelse af STEMI er dosisreduktion ikke nødvendig hos ældre, medmindre nyrefunktionen er nedsat (se ”Nedsat nyrefunktion” nedenfor og pkt.
English: The Thorinane pre-filled syringes are for single dose use only.
Danish: De fyldte Thorinane-sprøjter er kun til brug til en enkelt dosis.
English: In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the drug to 300 IU/mL (3 mg/mL).
Danish: For at sikre nøjagtigheden af den lille volumen, der skal injiceres, anbefales det at fortynde lægemidlet til 300 IE/ml (3 mg/ml).
English: When the container is full, give it to your doctor or home care nurse for disposal.
Danish: Når beholderen er fuld, skal du give den til din læge eller hjemmeplejesygeplejerske, så den kan blive bortskaffet.
English: Enoxaparin is a LMWH with a mean molecular weight of approximately 4,500 daltons, in which the antithrombotic and anticoagulant activities of standard heparin have been dissociated.
Danish: Enoxaparin er et lavmolekylært heparin med en gennemsnitlig molekylvægt på ca. 4.500 dalton, i hvilken standard-heparins antitrombotiske og antikoagulerende aktivitet er blevet adskilt.
English: Pharmacotherapeutic group: Antithrombotic agents, heparin group.
Danish: Farmakoterapeutisk klassifikation: Antithrombosemidler, heparin-gruppen.
English: In order to improve the LMWH traceability, it is recommended that health care professionals record the trade name and batch number of the administered product in the patient file.
Danish: For at forbedre sporbarheden af lavmolekylære hepariner anbefales det, at læger og sundhedspersonale noterer handelsnavn og batchnummer på det administrerede lægemiddel i patientjournalen.
English: • Your doctor will decide how long you should receive Thorinane.
Danish: • Lægen vil afgøre, hvor længe du skal have Thorinane.
English: This results in differences in pharmacokinetics and associated biological activities (e.g. anti-thrombin activity, and platelet interactions).
Danish: Dette resulterer i variationer i deres farmakokinetik og biologiske aktivitet (f.eks. antitrombin-aktivitet og trombocyt-interaktioner).
English: • If you have restricted mobility due to illness, you will normally be given 4,000 IU (40 mg) of Thorinane each day.
Danish: • Hvis du ligger i sengen/har begrænset bevægelighed på grund af sygdom, vil du normalt få 4.000 IE (40 mg) Thorinane dagligt.
English: Injection site nodules* (inflammatory nodules, which were not cystic enclosure of enoxaparin).
Danish: Knuder på injektionsstedet* (inflammatoriske knuder, der ikke var cystisk indkapsling af enoxaparin).
English: The volume of distribution of enoxaparin sodium anti-Xa activity is about 4.3 litres and is close to the blood volume.
Danish: Fordelingsvolumen af enoxaparinnatriums anti-Xa-aktivitet er ca. 4,3 liter og tæt på det samme som blodvolumen.
English: These factors are known to contribute to the overall antithrombotic effect of enoxaparin sodium.
Danish: Disse faktorer bidrager til enoxaparinnatriums samlede antitrombotiske effekt.
English: Withdraw 30 mL from the infusion bag with a syringe and discard the liquid.
Danish: Udtag 30 ml fra infusionsposen med en sprøjte og kasser væsken.
English: Beyond its anti-Xa/IIa activity, further antithrombotic and anti-inflammatory properties of enoxaparin have been identified in healthy subjects and patients as well as in non-clinical models.
Danish: Udover dets anti-Xa- og anti-IIa-aktivitet er der identificeret yderligere antitrombotiske og antiinflammatoriske egenskaber hos enoxaparin i studier hos raske forsøgspersoner og patienter såvel som i nonkliniske modeller.
English: If there is a need for earlier than 12 hours enoxaparin sodium preoperative prophylactic initiation (e.g. high risk patient waiting for a deferred orthopaedic surgery), the last injection should be administered no later than 12 hours prior to surgery and resumed 12 hours after surgery.
Danish: Hvis der er behov for at påbegynde profylaktisk behandling med enoxaparinnatrium mere end 12 timer før det kirurgiske indgreb (f.eks. en højrisiko-patient, der venter på udskudt ortopædkirurgi), bør den sidste injektion administreres senest 12 timer før det kirurgiske indgreb og genoptages 12 timer efter det kirurgiske indgreb.
English: See “Do not use Thorinane”.
Danish: Se afsnittet ”Brug ikke Thorinane”.
English: A linear relationship between anti-Xa plasma clearance and creatinine clearance at steady-state has been observed, which indicates decreased clearance of enoxaparin sodium in patients with reduced renal function.
Danish: Der er set et lineært forhold mellem plasma-clearance af anti-Xa og kreatinin-clearance ved steady state, hvilket tyder på nedsat clearance af enoxaparinnatrium hos patienter med nedsat nyrefunktion.
English: Remember: Do not inject yourself within 5 cm of your belly button or around existing scars or bruises.
Danish: Husk: Du må ikke give dig selv indsprøjtningen inden for 5 cm fra din navle eller fra ar eller blå mærker.
English: IV (Bolus) Injection (for acute STEMI indication only):
Danish: I.v.-(bolus) injektion (kun for indikationen akut STEMI):
English: Make sure you can see the place you are going to inject.
Danish: Sørg for, at du kan se det sted, hvor du vil give indsprøjtningen.
English: After 12 hours of the enoxaparin sodium injection, protamine administration may not be required.
Danish: 12 timer efter injektion af enoxaparinnatrium er det muligvis ikke nødvendigt at administrere protamin.
English: o For patients who undergo major orthopaedic surgery an extended thromboprophylaxis up to 5 weeks is recommended.
Danish: o Hos patienter, der får foretaget et større ortopædkirurgisk indgreb, anbefales forlænget tromboseprofylakse på op til 5 uger.
English: Prophylaxis of venous thromboembolic disease in medical patients with an acute illness expected to induce limitation of mobility
Danish: Profylakse mod venøs tromboembolisk sygdom hos medicinske patienter med en akut sygdom, der forventes at medføre begrænset mobilitet
English: In practice, if a confirmed significant decrease of the platelet count is observed (30 to 50 % of the initial value), enoxaparin sodium treatment must be immediately discontinued and the patient switched to another non-heparin anticoagulant alternative treatment.
Danish: I praksis betyder det, at hvis der observeres et signifikant fald i trombocyttallet (30-50 % af initialværdien), skal behandlingen med enoxaparinnatrium straks afbrydes og patienten skiftes over til en anden antikoagulansbehandling uden heparin.
English: Treatment with enoxaparin sodium is prescribed for at least 6 to 14 days whatever the recovery status (e.g. mobility).
Danish: Behandling med enoxaparinnatrium ordineres i mindst 6-14 dage uanset rekonvalescens-status (f.eks. mobilitet).
English: These include ATIII-dependent inhibition of other coagulation factors like factor VIIa, induction of endogenous Tissue Factor Pathway Inhibitor (TFPI) release as well as a reduced release of von Willebrand factor (vWF) from the vascular endothelium into the blood circulation.
Danish: Disse inkluderer ATIII-afhængig hæmning af andre koagulationsfaktorer som faktor VIIa, induktion af endogen Tissue Factor Pathway Inhibitor (TFPI)-afgivelse og reduceret afgivelse af von Willebrandfaktor (vWF) fra det vaskulære endotel til blodcirkulationen.
English: • - If you are allergic to enoxaparin sodium or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis du er allergisk over for enoxaparinnatrium eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: No difference in major bleeding was found between the enoxaparin sodium and the placebo group.
Danish: Der blev ikke observeret nogen forskel i alvorlige blødningshændelser mellem enoxaparinnatrium-gruppen og placebogruppen.
English: Careful clinical monitoring is advised and dose reduction might be considered in patients older than 75 years treated for STEMI (see sections 4.2 and 5.2).
Danish: Omhyggelig klinisk overvågning tilrådes, og dosisreduktion kan overvejes hos patienter over 75 år, der behandles for STEMI (se pkt.
English: • IV (bolus) injection (for acute STEMI indication only):
Danish: • Intravenøs (bolus) injektion (kun for indikationen akut STEMI):
English: • Medicinal products increasing potassium levels:
Danish: • Lægemidler, der øger kaliumkoncentrationen:
English: • You notice yellowing of your skin or eyes and your urine becomes darker in colour.
Danish: • Gulfarvning af huden eller øjnene og mørkfarvet urin.
English: Like other similar medicines (medicines to reduce blood clotting), Thorinane may cause bleeding which may potentially be life-threatening.
Danish: Thorinane kan som anden lignende medicin (blodfortyndende medicin) medføre blødning, som kan være livstruende.
English: If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae.
Danish: Hvis der er mistanke om symptomer på spinalt hæmatom, skal akut diagnosticering og behandling iværksættes og spinal dekompression overvejes, selv om denne behandling muligvis ikke forebygger eller reverserer neurologiske sequelae.
English: Studies conducted in pregnant rats and rabbits at SC doses of enoxaparin sodium up to 30 mg/kg/day did not reveal any evidence of teratogenic effects or foetotoxicity.
Danish: Studier udført hos drægtige rotter og kaniner ved subkutane doser af enoxaparinnatrium på op til 30 mg/kg/dag viste ingen evidens for teratogene virkninger eller føtotoksicitet.
English: An increase in exposure of enoxaparin sodium with prophylactic dosages (non-weight adjusted) has been observed in low-weight women (<45 kg) and low-weight men (<57 kg), which may lead to a higher risk of bleeding.
Danish: Der er set en øget eksponering for enoxaparinnatrium ved profylaktiske doser (ikke vægtjusteret) hos kvinder med lav legemsvægt (< 45 kg) og mænd med lav legemsvægt (< 57 kg), hvilket kan øge risikoen for blødning.
English: The pharmacokinetic parameters of enoxaparin sodium have been studied primarily in terms of the time course of plasma anti-Xa activity and also by anti-IIa activity, at the recommended dosage ranges after single and repeated SC administration and after single IV administration.
Danish: Enoxaparinnatriums farmakokinetiske parametre er primært blevet undersøgt ud fra varigheden af anti-Xa-aktivitet i plasma, men også ud fra anti-IIa-aktivitet ved de anbefalede doser efter enkelt og gentagen subkutan administration og efter en enkelt intravenøs injektion.
English: - enoxaparin sodium once a day versus heparin (-3.0 to 3.5)
Danish: - enoxaparinnatrium en gang dagligt versus heparin (-3,0 til 3,5)
English: This study included patients with heart failure (NYHA Class III or IV); acute respiratory failure or complicated chronic respiratory insufficiency, and acute infection or acute rheumatic; if associated with at least one VTE risk factor (age ≥75 years, cancer, previous VTE, obesity, varicose veins, hormone therapy, and chronic heart or respiratory failure).
Danish: Studiet inkluderede patienter med hjerteinsufficiens (NYHA-klasse III eller IV); akut respirationssvigt eller kompliceret kronisk respirationssvigt og akut infektion eller akut reumatisme; hvis det var associeret med mindst en VTE-risikofaktor (alder ≥75 år, cancer, tidligere VTE, fedme, varikøse vener, hormonbehandling og kronisk hjerte- eller respirationsinsufficiens).
English: Stop using Thorinane and talk to a doctor or nurse at once if you get any signs of a severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat or eyes).
Danish: Du skal straks stoppe med at bruge Thorinane og kontakte lægen eller sundhedspersonalet, hvis du får tegn på en alvorlig allergisk reaktion (f.eks. vejrtrækningsbesvær, hævelse af læber, mund, svælg eller øjne).
English: In surgical patients, haemorrhage complications were considered major: (1) if the haemorrhage caused a significant clinical event, or (2) if accompanied by haemoglobin decrease ≥ 2 g/dL or transfusion of 2 or more units of blood products.
Danish: Hos kirurgiske patienter blev blødning betragtet som alvorlig: (1) hvis blødningen medførte en klinisk signifikant hændelse, eller (2) hvis blødningen var ledsaget af fald i hæmoglobinkoncentrationen på ≥ 2 g/dl eller transfusion af 2 eller flere enheder blod.
English: In humans, there is no evidence that enoxaparin crosses the placental barrier during the second and third trimester of pregnancy.
Danish: Der er ingen evidens for, at enoxaparin passerer placentabarrieren i andet og tredje trimester hos mennesker.
English: • If you are using Thorinane to treat blood clots in your body and going to receive spinal or epidural anaesthesia or lumbar puncture within 24 hours.
Danish: • Hvis du får Thorinane til behandling af blodpropper i kroppen og inden for 24 timer skal have en rygmarvsbedøvelse eller en epiduralbedøvelse eller skal have foretaget lumbalpunktur.
English: Do not use if the date has passed.
Danish: Du må ikke bruge lægemidlet, hvis datoen er overskredet.
English: • Prednisolone, dexamethasone or other medicines used to treat asthma, rheumatoid arthritis and other conditions
Danish: • Prednisolon, dexamethason og andre lægemidler til behandling af astma, leddegigt og andre sygdomme
English: Overall list of possible side effects: Very common (may affect more than 1 in 10 people)
Danish: Samlet liste over bivirkninger Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer)
English: The syringe is pre-filled and ready to use.
Danish: Sprøjten er fyldt og klar til brug.
English: Injection should be made preferably when the patient is lying down.
Danish: • Injektionen udføres bedst, mens patienten ligger på ryggen.
English: Enoxaparin sodium pharmacokinetics appears to be linear over the recommended dosage ranges.
Danish: Enoxaparinnatriums farmakokinetik synes at være lineær ved de anbefalede dosisintervaller.
English: Clear, colourless to pale yellow solution.
Danish: Klar, farveløs til lysegul opløsning.
English: • Uncommon: Local irritation, skin necrosis at injection site
Danish: • Ikke almindelig: Lokal irritation, hudnekrose på injektionsstedet
English: • Acute coronary syndrome: - Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid.
Danish: • Akut koronarsyndrom: - Behandling af ustabil angina pectoris og myokardieinfarkt uden ST-elevation (NSTEMI) i kombination med oral acetylsalicylsyre.
English: Method of administration Thorinane should not be administered by the intramuscular route.
Danish: Administration Thorinane må ikke administreres intramuskulært.
English: • Osteoporosis (a condition where your bones are more likely to break) after long term use.
Danish: • Knogleskørhed (osteoporose - en sygdom, hvor du har en højere risiko for knoglebrud) efter langvarig brug.
English: • Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism.
Danish: • Profylakse mod venøs tromboembolisk sygdom hos medicinske patienter med akut sygdom (f.eks. akut hjertesvigt, respirationssvigt, svære infektioner eller reumatisk sygdom) og nedsat mobilitet med øget risiko for venøs tromboemboli.
English: • Thorinane is usually given by injection underneath the skin (subcutaneous).
Danish: • Thorinane gives normalt som en indsprøjtning under huden (subkutant).
English: Pregnant women with mechanical prosthetic heart valves may be at higher risk for thromboembolism.
Danish: Gravide kvinder med hjerteklapprotese kan have højere risiko for tromboemboli.
English: LMWHs are biological medicinal products.
Danish: Lavmolekylære hepariner er biologiske lægemidler.
English: The dose regimen of 150 IU/kg (1.5 mg/kg) administered once daily should be used in uncomplicated patients with low risk of VTE recurrence.
Danish: Dosisregimet på 150 IE/kg (1,5 mg/kg) en gang dagligt anvendes hos ukomplicerede patienter med lav risiko for tilbagevendende VTE.
English: Prevention of venous thromboembolic disease associated with surgery
Danish: Forebyggelse af venøs tromboembolisk sygdom i forbindelse med kirurgi
English: You will be given 2,000 IU (20 mg) or 4,000 IU (40 mg) of Thorinane each day.
Danish: Du vil få 2.000 IE (20 mg) eller 4.000 IE (40 mg) Thorinane dagligt.
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 Non-Steroidal 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: Also, tell your doctor if you have any problem with your spine or if you ever had spinal surgery.
Danish: Fortæl også lægen, hvis du har problemer med ryggen, eller hvis du nogensinde er blevet opereret i ryggen.
English: • If you are bleeding heavily or have a condition with a high risk of bleeding (such as stomach ulcer, recent surgery of the brain or eyes), including recent bleeding stroke.
Danish: • Hvis du bløder kraftigt, eller hvis du har en sygdom med en høj risiko for blødning (f.eks. mavesår, eller hvis du for nyligt er blevet opereret i hjernen eller øjnene), eller hvis du for nyligt har haft en hjerneblødning.
English: If a child accidentally injects or swallows Thorinane, take them to a hospital causualty department straight away.
Danish: Hvis et barn ved et uheld indsprøjter eller synker Thorinane, skal barnet straks bringes på skadestuen.
English: If there are clinical symptoms suggestive of HIT (any new episode of arterial and/or venous thromboembolism, any painful skin lesion at the injection site, any allergic or anaphylactoid reactions on treatment), platelet count should be measured.
Danish: Hvis der opstår kliniske symptomer, der tyder på HIT (ethvert nyt tilfælde af arteriel og/eller venøs tromboemboli, smertefuld hudlæsion omkring injektionsstedet, enhver allergisk eller anafylaktoid reaktion i løbet af behandlingen), bør trombocyttallet måles.
English: In these patients, careful clinical monitoring is advised, and biological monitoring by antiXa activity measurement might be considered (see sections 4.2 and 5.2).
Danish: Hos disse patienter anbefales omhyggelig klinisk overvågning og biologisk monitorering ved måling af anti-Xa-aktivitet kan overvejes (se pkt.
English: In comparison with heparin, enoxaparin sodium significantly reduced the combined incidence of angina pectoris, myocardial infarction and death, with a decrease of 19.8 to 16.6% (relative risk reduction of 16.2%) on day 14.
Danish: Sammenlignet med heparin reducerer enoxaparinnatrium signifikant hyppigheden af angina pectoris, myokardieinfarkt og død med et fald på 19,8 til 16,6 % (relativ risikoreduktion på 16,2 %) på dag 14.
English: 10 pre-filled syringes
Danish: 10 fyldte sprøjter
English: Thorinane can be used for two different types of heart attack called STEMI (ST segment elevation myocardial infarction) or Non STEMI (NSTEMI).
Danish: Thorinane kan anvendes ved to forskellige former for hjerteanfald, STEMI (myokardieinfarkt med STelevation) eller non-STEMI (NSTEMI, myokardieinfarkt uden ST-elevation).
English: • Moderate and mild renal impairment
Danish: • Moderat og let nedsat nyrefunktion
English: • Increased potassium in your blood.
Danish: • Forhøjet kalium i blodet.
English: The rates of venous thromboembolism at the end of the double-blind phase were 12.0 % (n=20) in the placebo group and 4.8% (n=8) in the enoxaparin sodium group; p=0.02.
Danish: Hyppigheden af venøs tromboemboli ved afslutningen af den dobbeltblinde fase var 12,0 % (n=20) i placebogruppen og 4,8 % (n=8) i enoxaparinnatrium-gruppen; p=0,02.
English: STEMI type of heart attack if you are 75 years old or older:
Danish: Hjerteanfald af typen STEMI, hvis du er 75 år og derover:
English: No pharmacokinetic interactions were observed between enoxaparin sodium and thrombolytics when administered concomitantly.
Danish: Der blev ikke observeret farmakokinetiske interaktioner mellem enoxaparinnatrium og trombolytika ved samtidig administration.
English: • Spinal/Epidural anaesthesia or lumbar puncture
Danish: • Spinal-/epiduralanæstesi eller lumbalpunktur
English: The SC injections of enoxaparin sodium were given until hospital discharge or for a maximum of eight days (whichever came first).
Danish: De subkutane injektioner med enoxaparinnatrium blev administreret indtil udskrivning eller i maksimalt 8 dage (det, der først forekom).
English: All patients also received warfarin sodium (dose adjusted according to prothrombin time to achieve an INR of 2.0 to 3.0), commencing within 72 hours of initiation of enoxaparin sodium or standard heparin therapy, and continuing for 90 days.
Danish: Alle patienter fik også warfarinnatrium (dosis justeres i henhold til protrombintid for at opnå INR på 2,0 til 3,0) inden for 72 timer efter initiering af enoxaparinnatrium eller standard-heparin og fortsatte behandlingen i 90 dage.
English: If you stop using Thorinane
Danish: Hvis du holder op med at bruge Thorinane
English: Patients received enoxaparin sodium (4,000 IU (40 mg) SC) daily for 6 to 10 days and were then randomly assigned to receive either enoxaparin sodium or placebo for another 21 days.
Danish: Patienterne fik enoxaparinnatrium (4.000 IE (40 mg) subkutant) dagligt i 6 til 10 dage og blev derefter randomiseret til at få enten enoxaparinnatrium eller placebo i yderligere 21 dage.
English: Therefore, careful clinical monitoring is advised in these patients (see section 5.2).
Danish: Derfor tilrådes omhyggelig klinisk overvågning af disse patienter (se pkt.
English: This helps your body to break them down and stops them from causing you harm.
Danish: Det hjælper kroppen med at nedbryde
English: • Medicines which increase potassium level in your blood such as potassium salts, water pills, some medicines for heart problems.
Danish: • Medicin, som øger indholdet at kalium i blodet, f.eks. kaliumholdig salterstatning, vanddrivende midler, nogle typer hjertemedicin.
English: - Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).
Danish: - Behandling af akut myokardieinfarkt med ST-elevation (STEMI) inklusive patienter, som skal i medicinsk behandling eller efterfølgende gennemgå perkutan koronar intervention (PCI).