FrancophonIA/ELRC3.0 huggingface dataset:
English: Inhixa can be used for two different types of heart attack called STEMI (ST segment elevation myocardial infarction) or Non STEMI (NSTEMI).
Danish: Inhixa kan anvendes ved to forskellige former for hjerteanfald, STEMI (myokardieinfarkt med STelevation) eller non-STEMI (NSTEMI, myokardieinfarkt uden ST-elevation).
English: • Stop blood clots from forming in your blood in the following situations: o Before and after an operation 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) o After a heart attack
Danish: • At forhindre, at der dannes blodpropper i blodet i følgende situationer: o Før og efter en operation 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) o Efter et hjertetilfælde
English: Your doctor will request you perform blood tests called INR and tell you when to start Inhixa 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 Inhixa.
English: Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of enoxaparin sodium is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known.
Danish: Det anbefales at anlægge eller fjerne epiduralkatetre eller udføre lumbalpunktur på et tidspunkt, hvor enoxaparinnatriums antitrombotiske virkning er lav; den præcise tid, der er nødvendig for at nå en tilstrækkeligt lav antikoagulerende virkning hos den enkelte patient, er imidlertid ikke kendt.
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 såsom nadroparin, tinzaparin eller dalteparin.
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 (såsom mavesår, eller hvis du for nyligt er blevet opereret i hjernen eller øjnene), eller hvis du for nyligt har haft en hjerneblødning.
English: Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients Individual thromboembolic risk for patients can be estimated using validated risk stratification model.
Danish: Profylakse af venøs tromboembolisk sygdom hos kirurgiske patienter med moderat og høj risiko Den enkelte patients risiko for tromboemboli kan estimeres ved hjælp af en valideret risikostratifikationsmodel.
English: • Acetylsalicylic acid (ASA), clopidogrel or other medicines used to stop blood clots from forming (see also 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: Total VTE (%)
Danish: VTE totalt (%)
English: For treatment of acute STEMI in elderly patients ≥75 years of age, an initial intravenous bolus must not be used.
Danish: Ved behandling af akut STEMI hos ældre patienter ≥ 75 år må der ikke gives initial intravenøs bolus.
English: Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 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: Hyppigheden er defineret på følgende måde: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til <1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • Your doctor will decide how long you should receive Inhixa.
Danish: • Lægen vil afgøre, hvor længe du skal behandles med Inhixa.
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, infarktets lokation, diabetes i anamnesen, myokardieinfarkt i anamnesen, det administrerede fibrinolytikum samt tid til behandlingsstart med studielægemidlet.
English: Dosing regimen
Danish: Dodidregime
English: This helps your body to break them down and stop them causing you harm.
Danish: Det hjælper kroppen med at nedbryde blodpropperne, så de ikke gør skade.
English: 6) Hold the syringe so that the needle is pointing downwards (vertically at a 90º angle).
Danish: 6) Hold sprøjten, så nålen peger nedad (lodret i en vinkel på 90º).
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 (dosisjusteret 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: 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 kirurgiske indgreb for abdominal- eller bækkencancer reducerede signifikant forekomsten af trombose påvist ved venografi sammenlignet med profylakse med enoxaparinnatrium i en uge.
English: Children and adolescents The safety and efficacy of Inhixa has not been evaluated in children or adolescents.
Danish: Børn og unge Sikkerheden og effektiviteten af Inhixia er ikke blevet evalueret hos børn og unge.
English: If a child accidentally injects or swallows Inhixa, take them to a hospital causualty department straight away.
Danish: Hvis et barn ved et uheld indsprøjter eller synker Inhixa, skal barnet straks bringes på skadestuen.
English: Like other similar medicines (medicines to reduce blood clotting), Inhixa may cause bleeding which may potentially be life-threatening.
Danish: Inhixa kan som anden lignende medicin (blodfortyndende medicin) medføre blødning, som kan være livstruende.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske læge midler skal det administrerede produkts handelsnavn og batchnummer tydeligt registreres.
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 såsom svært overvægtige patienter, patienter med symptomatisk PE, cancer, tilbagevendende VTE eller proksimal (vena iliaca) trombose.
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-/IIa-aktivitet er der identificeret yderligere antitrombotiske og antiinflammatoriske egenskaber hos enoxaparin i studier hos raske forsøgspersoner og patienter såvel som i non-kliniske modeller.
English: Other medicines and Inhixa Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Inhixa Fortæl det altid til lægen, apotekspersonalet eller sygeplejersken, hvis du tager anden medicin eller har gjort det for nylig.
English: Treatment of acute STEMI (patients over 75)
Danish: Behandling af akut STEMI (patienter over 75
English: • If you have restricted mobility due to illness, you will normally be given 4,000 IU (40 mg) of
Danish: • Hvis du ligger i sengen/har begrænset bevægelighed på grund af sygdom, vil du normalt få 4.000 IE (40 mg) Inhixa dagligt.
English: • Common: Headache*
Danish: • Almindelig: Hovedpine*
English: Enoxaparin sodium is primarily metabolized in the liver by desulfation and/or depolymerisation to lower molecular weight species with much reduced biological potency.
Danish: Enoxaparinnatrium metaboliseres hovedsageligt i leveren via desulfatering og/eller depolymerisering til metabolitter, der har en lavere molekylevægt og meget reduceret biologisk potens.
English: • Very common: Hepatic enzyme increases (mainly transaminases > 3 times the upper limit of normality)
Danish: • Meget almindelig: Øgede leverenzymer (hovedsageligt transaminaser> 3 gange normal øvre grænse)
English: Inhixa should not be used interchangeably with other medicines belonging to the group of low molecular weight heparins.
Danish: Inhixa bør ikke umiddelbart udskiftes med anden medicin, der tilhører gruppen af lavmolekylære hepariner.
English: Following repeated subcutaneous administration no accumulation takes place.
Danish: Der er ingen akkumulering efter gentagen subkutan administration.
English: Do not use Inhixa
Danish: Brug ikke Inhixa:
English: Concomitant use with caution: 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: • If you are using Inhixa 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 Inhixa til behandling af blodpropper i kroppen og inden for 24 timer skal have en rygmarvsbedøvelse eller en epiduralbedøvelse eller skal have foretaget lumbalpunktur.
English: The subcutaneous 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: • Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery.
Danish: • Profylakse af venøs tromboembolisk sygdom hos kirurgiske patienter med moderat og høj risiko, især hos patienter, der får foretaget ortopædisk eller generel kirurgi, herunder cancerkirurgi.
English: What you need to know before you use Inhixa
Danish: Det skal du vide, før du begynder at bruge Inhixa
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 subcutaneous administration and after single intravenous 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: Studies conducted in pregnant rats and rabbits at subcutaneous 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: There were no significant differences in major haemorrhages, although a haemorrhage at the site of the subcutaneous injection was more frequent.
Danish: Der var ingen signifikante forskelle i alvorlige blødningsepisoder, selvom blødning omkring det subkutane injektionssted var hyppigere.
English: Treatment of unstable angina and NSTEMI
Danish: Behandling af ustabil angina pectoris og NSTEMI
English: You will be given 2,000 IU (20 mg) or 4,000 IU (40 mg) of Inhixa each day.
Danish: Du vil få 2.000 IE (20 mg) eller 4.000 IE (40 mg) Inhixa dagligt.
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 anbefales, og dosisreduktion kan overvejes hos patienter over 75 år, der behandles for STEMI (se pkt.
English: When the container is full, dispose of it as your doctor or pharmacist has instructed.
Danish: Når beholderen er fuld, skal du bortskaffe den, som din læge eller apotekespersonalet har instrueret.
English: Other in-use storage times and conditions are the responsibility of the user.
Danish: Andre opbevaringstider og forhold efer åbning er brugerens ansvar.
English: Injection should be made preferably when the patient is lying down.
Danish: Det er bedst at give injektionen, mens patienten ligger ned.
English: Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children.
Danish: Benzylakohol er blevet forbundet med risikoen for alvorlige bivirkninger, inklusive vejrtræknigsproblemer (kaldet ”gispende vejrtrækning”) hos små børn.
English: No data are available in patients using enoxaparin sodium for prophylaxis or treatment and during haemodialysis sessions.
Danish: Der foreligger ingen data for brug af enoxaparinnatrium til profylakse eller behandling og under hæmodialyse.
English: • Decreased red blood cell count.
Danish: • Nedsat antal røde blodlegemer.
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: Patients received enoxaparin sodium (4,000 IU (40 mg) subcutaneously) 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: What Inhixa contains - The active substance is enoxaparin sodium.
Danish: Inhixa indeholder - Aktivt stof: enoxaparinnatrium.
English: 2) Stopping blood clots forming in your blood.
Danish: 2) Det forhindrer, at der dannes blodpropper i blodet.
English: Medicinal products that increase serum potassium levels may be administered concurrently with enoxaparin sodium under careful clinical and laboratory monitoring (see sections 4.4 and 4.8).
Danish: Lægemidler, der øger serumkaliumniveauet, kan administreres samtidig med enoxaparinnatrium under omhyggelig klinisk og laboratoriemæssig overvågning (se pkt.
English: Chemical and physical in-use stability has been demonstrated for 8 hours at 25°C.
Danish: Kemisk og fysisk stabilitet under brug er påvist i 8 timer ved 25 °C.
English: Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.
Danish: Kemisk og fysisk stabilitet i brug er påvist i 28 dage ved 25 °C.
English: Inhixa multidose vial contains benzyl alcohol and must not be used in newborn and premature neonates (see section 4.3).
Danish: Inhixa flerdosis hætteglas indeholder benzylalkohol og må ikke anvendes til nyfødte og for tidligt fødte spædbørn (se pkt.
English: Pregnant women with mechanical prosthetic heart valves may be at higher risk for thromboembolism.
Danish: Gravide kvinder med hjerteklapprotese kan have øget risiko for tromboemboli.
English: If you stop using Inhixa
Danish: Hvis du holder op med at bruge Inhixa
English: If a manual compression method is used, sheath should be removed 6 hours after the last intravenous/subcutaneous enoxaparin sodium injection.
Danish: Hvis en manuel kompressionsmetode anvendes, skal sheathen fjernes 6 timer efter den sidste intravenøse/subkutane injektion af enoxaparinnatrium.
English: Marketing Authorisation Holder Techdow Europe AB Kåbovägen 32
Danish: Indehaver af markedsføringstilladelsen Techdow Europe AB Kåbovägen 32
English: Check your abdomen to see if the last injection caused any redness, change in skin colour, swelling, oozing or is still painful, if so talk to your doctor or nurse.
Danish: - Undersøg huden på din mave for at se, om den sidste indsprøjtning har forårsaget rødme, ændring af hudfarven, hævelse, udsivning, eller om stedet stadig er ømt/smertefuldt.
English: Treatment of acute STEMI (patients under 75)
Danish: Behandling af akut STEMI (patienter under 75 år)
English: 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/epidural anæstesi eller lumbalpunktur inden for 24 timer efter administration af terapeutiske doser enoxaparinnatrium (se også pkt.
English: Besides the anticoagulant effects of enoxaparin sodium, there was no evidence of adverse effects at 15 mg/kg/day in the 13-week subcutaneous toxicity studies both in rats and dogs and at 10 mg/kg/day in the 26-week subcutaneous and intravenous toxicity studies both in rats, and monkeys.
Danish: Udover enoxaparinnatriums antikoagulerende virkninger var der ikke evidens for bivirkninger ved 15 mg/kg/dag subkutant i de 13 uger lange toksicitetsstudier hos rotter og hunde eller i de 26 uger lange toksicitetsstudier hos rotter og aber ved 10 mg/kg/dag subkutant og intravenøst.
English: All Treated Extended Prophylaxis Patients
Danish: Alle patienter behandlet med forlænget profylakse
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: LMWHs are biological medicinal products In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: Lavmolekylære hepariner er biologiske lægemidler.For at forbedre sporbarheden af biologiske læge midler skal det administrerede produkts handelsnavn og batchnummer tydeligt registreres.
English: Enoxaparin sodium is a biological substance obtained by alkaline depolymerisation 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: However, even with high doses of protamine, the anti-Xa activity of enoxaparin sodium is never completely neutralized (maximum about 60%) (see the prescribing information for protamine salts).
Danish: Selv høje doser protamin neutraliserer imidlertid ikke enoxaparinnatriums anti-Xa-aktivitet fuldt ud (højst cirka 60 %) (se produktresuméet for protaminsalte).
English: Not all pack sizes may be marketed.
Danish: Ikke alle pakninsstørrelser er nødvendigvis markedsført.
English: For all indications except STEMI, no dose reduction is necessary in the elderly patients, unless kidney function is impaired (see below paragraph “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 afsnittet ”Nedsat nyrefunktion” nedenfor og pkt.
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 dosisregimer med enoxaparinnatrium på 4.000 IE (40 mg) en gang dagligt eller lavere.
English: Enoxaparin sodium is administered by deep subcutaneous injection.
Danish: Enoxaparinnatrium administreres som dyb subkutan injektion.
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 af kalium i blodet, f.eks. kaliumholdig salterstatning, vanddrivende midler, nogle typer hjertemedicin.
English: Pack-sizes of 1 or 5 vials containing 10 mL.
Danish: Pakningsstørrelser på 1 eller 5 hætteglas indeholdende 10 ml.
English: • Treat blood clots that are in your blood
Danish: • At behandle blodpropper i blodet
English: Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe, and in such case the volume shall be rounded up to the nearest graduation.
Danish: Vær opmærksom på, at det i nogen tilfælde er ikke muligt at opnå en præcis dosis på grund af gradueringen på injektionssprøjten, og i sådanne tilfælde bør volumen rundes op til den nærmeste delestreg.
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 epidural anæstesi eller lokoregional anæstesi, når enoxaparinnatrium er blevet anvendt til behandling inden for de forudgående 24 timer (se pkt.
English: Driving and using machines Inhixa does not affect the ability to drive and operate machinery.
Danish: Trafik- og arbejdssikkerhed Inhixa påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: Haemorrhage As with other anticoagulants, bleeding may occur at any site.
Danish: • Blødning Som med andre antikoagulantia kan der forekomme blødning alle steder.
English: Enoxaparin sodium was found to have no effect on fertility or reproductive performance of male and female rats at subcutaneous 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: • At the same time you will also be given Inhixa as an injection underneath your skin (subcutaneous injection).
Danish: • Straks efter indsprøjtningen i venen vil du også få lægemidlet som en indsprøjtning under huden (subkutan injektion).
English: If you forget to use Inhixa
Danish: Hvis du har glemt at tage Inhixa
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: • Skin necrosis / cutaneous vasculitis
Danish: • Hudnekrose/kutan vasculitis
English: - At doses used for prophylaxis
Danish: - Ved doser til profylakse
English: Accidental overdose with enoxaparin sodium after intravenous, extracorporeal or subcutaneous administration may lead to haemorrhagic complications.
Danish: Utilsigtet overdosering med enoxaparinnatrium efter intravenøs, ekstrakorporal eller subkutan administration kan medføre blødningskomplikationer.
English: Inhixa each day.
Danish: subkutan en gang dagligt
English: • Acetylsalicylic acid is recommended for all patients without contraindications at an initial oral loading dose of 150-300 mg (in acetylsalicylic acid-naive patients) and a maintenance dose of 75-325 mg/day long-term regardless of treatment strategy.
Danish: • Det anbefales at give acetylsalicylsyre til alle patienter uden kontraindikationer med en initial oral startdosis på 150-300 mg (hos acetylsalicylsyre-naive patienter) og en langvarig vedligeholdelsesdosis på 75-325 mg/dag uanset behandlingsstrategi.