FrancophonIA/ELRC3.0 huggingface dataset:
English: • That Tracleer is teratogenic in animals
Danish: • At Tracleer er teratogent hos dyr
English: • That Tracleer causes a decrease in haemoglobin and the need for regular blood tests
Danish: • At Tracleer medfører et fald i hæmoglobin og at der er behov for regelmæssige blodprøver
English: • That Tracleer is hepatotoxic and the need for regular monitoring of liver function
Danish: • At Tracleer er hepatotoksiskt og at der er behov for regelmæssig kontrol af leverfunktionen
English: • Patient Information Booklet/Patient Reminder Card
Danish: • Informationsbrochure til patienter/huskekort til patienter
English: The Member States shall ensure that the MAH shall set up a surveillance programme/registry to collect information on the demographics, safety and outcome data from patients prescribed Tracleer to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
Danish: Medlemslandene skal sikre, at indehaveren af markedsføringstilladelsen implementerer et overvågningsprogram/register til indsamling af demografisk information, information om sikkerhed og resultater fra patienter, der har fået ordineret Tracleer med henblik på at reducere antallet af nye fingersår hos patienter med systemisk sklerose og aktiv fingersårssygdom.
English: • That women of child bearing potential must use effective contraception
Danish: • At kvinder i den fødedygtige alder skal anvende effektiv prævention
English: The MAH shall agree with each National Competent Authority the content of a "Reminder Letter" to all known prescribers of Tracleer, reminding them of the safety concerns with Tracleer in relation to pregnancy.
Danish: Indehaveren af markedsføringstilladelsen skal i samarbejde med de nationale kompetente myndigheder sikre indholdet af en ”huskeseddel” til alle, som ordinerer Tracleer, for at gøre opmærksom på sikkerhedsforholdene omkring Tracleer i forhold til graviditet.
English: The patient information booklet for patients prescribed Tracleer should include the following key elements:
Danish: Patientinformationen skal indeholde følgende information:
English: The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that prior to prescribing all health care professionals who intend to prescribe and/or dispense Tracleer are provided with a Prescriber Kit containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal sammen med den kompetente, nationale myndighed i hvert land aftale detaljerne omkring et kontrolleret distributionssystem og implementere et sådant program nationalt for at sikre, at alt sundhedspersonale, som har til hensigt at ordinere og/eller udlevere Tracleer, modtager en informationspakke til læger indeholdende følgende:
English: Stop taking the vitamin-K antagonist.
Danish: Du skal stoppe med at tage K-vitamin-antagonisten.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Danish: Det muliggør løbende monitorering af benefit/risk-forholdet for lægemidlet.
English: This is a preservative.
Danish: Det er et konserveringsmiddel.
English: • If you have a painful rash of dark red spots under the skin which do not go away when you put pressure on them.
Danish: • Hvis du får et smertefuldt udslæt med mørkerøde pletter under huden, der ikke går væk, når man trykker på dem.
English: Pharmacotherapeutic group: Antithrombotic agent, heparin group, ATC code: B01A B05
Danish: Farmakoterapeutisk klassifikation: Antitrombosemidler, heparin-gruppen, ATC-kode: B01A B05
English: It should not be mixed or coadministered with other medications.
Danish: Det bør ikke blandes eller administreres sammen med andre lægemidler.
English: *p value versus placebo =0.008 #p value versus placebo =0.537
Danish: *p-værdi versus placebo =0,008 #p-værdi versus placebo =0,537
English: As benzyl alcohol may cross the placenta, it is recommended to use a formulation that does not contain benzyl alcohol.
Danish: Eftersom benzylalkohol kan passere placenta, anbefales det at anvende en formulering, der ikke indeholder benzylalkohol.
English: A total of 1,102 patients were enrolled in the study, and 1073 patients were treated.
Danish: I alt 1.102 patienter deltog i studiet, og 1.073 patienter blev behandlet.
English: It is recommended to use the LOVENOX formulation without benzyl alcohol in pregnant women.
Danish: Det anbefales at bruge LOVENOX uden benzylalkohol til gravide kvinder.
English: Do not use this medicine if you notice {description of the visible signs of deterioration}.
Danish: Brug ikke lægemidlet, hvis {beskrivelse af synlige tegn på nedbrydning}.
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: These anticoagulant activities are mediated through anti-thrombin III (ATIII) resulting in antithrombotic activities in humans.
Danish: Disse antikoagulerende aktiviteter medieres af antitrombin III (ATIII), hvilket resulterer i antitrombotisk virkning hos mennesker.
English: • Benzyl alcohol
Danish: • Benzylalkohol
English: This medicinal product is authorised in the Member States of the EEA under the following names: {Name of the Member State} {Name of the medicinal product} {Name of the Member State} {Name of the medicinal product} [See Annex I - To be completed nationally] [For referral procedures, as appropriate] This leaflet was last revised in {MM/YYYY} {month YYYY}.
Danish: Dette lægemiddel er godkendt i EØSs medlemslande under følgende navne: {Medlemslandets navn} {Lægemidlets navn} {Medlemslandets navn} {Lægemidlets navn} [Se bilag I - Udfyldes nationalt] [For referral procedures, as appropriate] Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ} {måned ÅÅÅÅ}.
English: • you are underweight or overweight
Danish: • hvis du vejer for lidt eller for meget
English: Injection should be made preferably when the patient is lying down.
Danish: Injektionen udføres bedst, mens patienten ligger på ryggen.
English: These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and antiIIa 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: This reduction in the combined incidence was maintained after 30 days (from 23.3 to 19.8%; relative risk reduction of
Danish: Faldet i den samlede incidens var opretholdt efter 30 dage (fra 23,3 til 19,8 %; relativ risikoreduktion på 15 %).
English: • When you go home, you may need to continue to use LOVENOX (and associated names) and give it yourself (see instructions below on how to do this).
Danish: • Når du bliver udskrevet, skal du muligvis fortsætte med at bruge LOVENOX (og relaterede navne) og give det til dig selv (se nedenstående anvisninger i, hvordan du skal gøre dette).
English: The amount of LOVENOX (and associated names) given to you will depend on your age and the kind of heart attack you have had.
Danish: Den dosis LOVENOX (og relaterede navne), du får, afhænger af din alder og den type hjerteanfald, du har haft.
English: Subcutaneous, intravenous use.
Danish: Subkutan, intravenøs anvendelse.
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 maximum amount of LOVENOX (and associated names) given for the first two injections is 7,500 IU (75 mg).
Danish: • Den højeste dosis LOVENOX (og relaterede navne), der gives i de to første indsprøjtninger, er 7.500 IE (75 mg).
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: • Very common: Hepatic enzyme increases (mainly transaminases > 3 times the upper limit of normality)
Danish: • Meget almindelig: Forhøjede leverenzymer (hovedsageligt aminotransferase > 3 gange normal øvre grænse)
English: • If the patient is a premature or newborn baby up to 1 month because of the risk of severe toxicity including abnormal respiration (“gasping syndrome”).
Danish: • Hvis patienten er et for tidligt født barn eller nyfødt (op til 1 måned gammel) på grund af risiko for alvorlig forgiftning, herunder vejrtrækningsforstyrrelser (”gasping syndrome”).
English: The administration of medicinal product containing benzyl alcohol as a preservative to neonates has been associated with a fatal “Gasping Syndrome” (see section 4.3).
Danish: Administration af lægemidler indeholdende konserveringsmidlet benzylalkohol til for tidligt fødte børn er blevet associeret med dødeligt ”gasping syndrome” (se pkt.
English: Stop using LOVENOX (and associated names) 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 LOVENOX (og relaterede navne) 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: • Hypersensitivity to benzyl alcohol;
Danish: • Overfølsomhed over for benzylalkohol.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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: Should thrombocytopenia occur, it usually appears between the 5th and the 21st day following the beginning of enoxaparin sodium treatment.
Danish: Skulle trombocytopeni opstå, sker det oftest mellem den 5. og 21. dag efter behandlingsstart med enoxaparinnatrium.
English: Important information about some of the ingredients of LOVENOX (and associated names) LOVENOX (and associated names) contains benzyl alcohol [benzyl alcohol content to be completed nationally].
Danish: Vigtig information om et indholdsstof i LOVENOX (og relaterede navne) LOVENOX (og relaterede navne) indeholder benzylalkohol [mængden af benzylalkohol udfyldes nationalt].
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/risk vurdering, hvor både risikoen for trombose og risikoen for blødning under proceduren og patientensrisikofaktorer tages i betragtning.
English: Therefore, careful clinical monitoring is advised in these patients (see section
Danish: Derfor tilrådes omhyggelig klinisk overvågning af disse patienter (se pkt.
English: • An initial dose of 3,000 IU (30 mg) of LOVENOX (and associated names) will be given as injection into your vein.
Danish: • Du får en startdosis på 3.000 IE (30 mg) LOVENOX (og relaterede navne) som en indsprøjtning i en vene.
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: You will be given 2,000 IU (20 mg) or 4,000 IU (40 mg) of LOVENOX (and associated names) each day.
Danish: Du vil få 2.000 IE (20 mg) eller 4.000 IE (40 mg) LOVENOX (og relaterede navne) dagligt.
English: It may cause toxic and allergic reactions in infants up to 3 years old.
Danish: Det kan give forgiftningsreaktioner og allergiske reaktioner hos spædbørn og børn op til 3 år.
English: • Other medicinal products affecting haemostasis such as: - Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, and glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding, - Dextran 40, - Systemic glucocorticoids.
Danish: • Andre lægemidler, der påvirker hæmostasen, som f.eks.: - Trombocytfunktionshæmmere, inclusive acetylsalicylsyre i antiaggregerende dosis (kardiobeskyttelse), clopidogrel, ticlopidin og glykoprotein IIb/IIIa-antagonister, indiceret ved akut koronarsyndrom på grund af blødningsrisikoen, - Dextran 40, - Systemiske glukokortikoider.
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 Willebrand-faktor (vWF) fra det vaskulære endotel til blodcirkulationen.
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 thrombocytopeniawithin 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: 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 lowweight 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: • If you have problems with your kidneys you may be given a smaller amount of LOVENOX (and associated names).
Danish: • Hvis du har problemer med nyrerne, vil du muligvis få en mindre dosis LOVENOX (og relaterede navne).
English: In moderate risk patients, enoxaparin sodium treatment should be maintained for a minimal period of 7-10 days whatever the recovery status (e.g. mobility).
Danish: Hos patienter med moderat risiko bør enoxaparinnatrium gives i mindst 7-10 dage uanset rekonvalescens-status (f.eks. mobilitet).
English: METHOD OF ADMINISTRATION SC/ IV
Danish: ADMINISTRATIONSMETODE s.c./i.v.
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: Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (< 1/10,000) or not known (cannot be estimated from available data).
Danish: 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 (<
English: • LOVENOX (and associated names) can be given by injection into your vein (intravenous) after certain types of heart attack or operation.
Danish: • LOVENOX (og relaterede navne) kan gives som en indsprøjtning i en vene (intravenøst) efter bestemte typer hjerteanfald eller operationer.
English: The absolute bioavailability of enoxaparin sodium after SC injection, based on anti-Xa activity, is close to 100%.
Danish: Enoxaparins absolutte biotilgængelighed efter subkutan injektion er næsten 100 %, baseret på anti-Xaaktivitet.
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 26week 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 are using LOVENOX (and associated names) 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 LOVENOX (og relaterede navne) til behandling af blodpropper i kroppen og inden for 24 timer skal have en rygmarvsbedøvelse eller en epiduralbedøvelse eller skal have foretaget lumbalpunktur.
English: LOVENOX (and associated names) contains benzyl alcohol and must not be used in newborn and premature neonates (see section 4.3).
Danish: LOVENOX (og relaterede navne) indeholder benzylalkohol og må ikke anvendes til nyfødte og for tidligt fødte børn (se pkt.
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 vaskulære abnormiteter.
English: LOVENOX (and associated names) works in two ways.
Danish: LOVENOX (og relaterede navne) virker på to måder.
English: 6.6 Special precautions for disposal and other handling INSTRUCTIONS FOR USE: [To be completed nationally] Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: 6.6 Regler for bortskaffelse og anden håndtering BRUGERVEJLEDNING: [Udfyldes nationalt] Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
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
Danish: Omhyggelig klinisk overvågning tilrådes, og dosisreduktion kan overvejes hos patienter over 75 år, der behandles for STEMI (se pkt.
English: METHOD OF ADMINISTRATION Extracorporeal use
Danish: ADMINISTRATIONSMETODE Ekstrakorporal anvendelse
English: DATE OF REVISION OF THE TEXT {MM/YYYY} {DD/MM/YYYY} {DD month YYYY}
Danish: DATO FOR ÆNDRING AF TEKSTEN {MM/ÅÅÅÅ} {DD/MM/ÅÅÅÅ} {DD måned ÅÅÅÅ} [Udfyldes nationalt]
English: If a child accidentally injects or swallows LOVENOX (and associated names), take them to a hospital causualty department straight away.
Danish: Hvis et barn ved et uheld indsprøjter eller synker LOVENOX (og relaterede navne), skal barnet straks bringes på skadestuen.
English: • Common: Injection site haematoma, injection site pain, other injection site reaction (such as oedema, haemorrhage, hypersensitivity, inflammation, mass, pain, or reaction)
Danish: • Almindelig: Hæmatom på injektionsstedet, smerter på injektionsstedet, andre reaktioner på injektionsstedet (såsom ødem, blødning, overfølsomhed, inflammation, udfyldning, smerter eller reaktioner)
English: - Changing from blood thinners called vitamin-K antagonists (e.g. warfarin) to LOVENOX (and associated names)
Danish: - Skift fra blodfortyndende medicin kaldet K-vitamin-antagonister (f.eks. warfarin) til LOVENOX (og relaterede navne)
English: Talk to your doctor or pharmacist before using LOVENOX (and associated names) if:
Danish: Kontakt lægen eller apotekspersonalet, før du bruger LOVENOX (og relaterede navne):
English: In surgical patients, haemorrhage complications were considered major: (1) if the haemorrhage caused a significant clinical event, or (2) if accompanied by a 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: Enoxaparin sodium is to be used with extreme caution in patients with a history (>100 days) of heparin-induced 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: 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 75325 mg/day long-term regardless of treatment strategy.
Danish: Medmindre det er kontraindiceret anbefales acetylsalicylsyre til alle patienter med en initial oral startdosis på 150-300 mg (hos acetylsalicylsyre-naive patienter) og en langvarig vedligeholdelsesdosis på 75-325 mg/dag uanset behandlingsstrategi.
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 mod 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: • If you have restricted mobility due to illness, you will normally be given 4,000 IU (40 mg) of LOVENOX (and associated names) each day.
Danish: • Hvis du ligger i sengen/har begrænset bevægelighed på grund af sygdom, vil du normalt få 4.000 IE (40 mg) LOVENOX (og relaterede navne) dagligt.
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 mod venøs tromboembolisk sygdom hos kirurgiske patienter med moderat og høj risiko, især hos patienter, der får foretaget ortopædisk eller generel kirurgi, herunder onkologisk kirurgi.
English: [To be completed nationally] [See Annex I - To be completed nationally] [For referral procedures]
Danish: [Udfyldes nationalt] [Se bilag I - Udfyldes nationalt] [For referral procedures]
English: In these patients, careful clinical monitoring is advised, and biological monitoring by anti-Xa activity measurement might be considered (see section 5.2).
Danish: Hos disse patienter anbefales omhyggelig klinisk overvågning og biologisk monitorering ved måling af anti-Xa-aktivitet kan overvejes (se pkt.
English: No dose reduction is necessary in the elderly patients in haemodialysis indication.
Danish: Ældre Dosisjustering er ikke nødvendig hos ældre patienter ved hæmodialyseindikationen.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {DD month YYYY} Date of latest renewal: {DD month YYYY}
Danish: Dato for første markedsføringstilladelse: {DD måned ÅÅÅÅ} Dato for seneste fornyelse: {DD måned ÅÅÅÅ}