FrancophonIA/ELRC3.0 huggingface dataset:
English: Inactivated Leptospira strains: - L. interrogans serogroup Canicola serovar Portland-vere
Danish: Inaktiveret Leptospira stammer: - L. interogans serogruppe Canicola serovar Portland-vere 3550-7100 E1
English: - L. interrogans serogroup Australis serovar Bratislava (strain As-05-073)
Danish: Copenhageni (stramme Ic-02-001) - L. interrogans serogruppe Australis serovar Bratislava
English: Every 24 hours
Danish: Hver 24. time
English: Not know (frequency cannot be estimated from the available data)
Danish: Ikke kendt (frekvensen kan ikke fastslås ud fra tilgængelige data)
English: Management of overdose should be supportive.
Danish: Behandling af overdosering skal være understøttende.
English: In children over one year old:
Danish: Børn over 1 år
English: The initial volume of distribution is about 9 to 12 liters.
Danish: Det initiale fordelingsvolumen er ca. 9-12 liter.
English: You should specifically tell your doctor if you take:
Danish: De skal især fortælle det til lægen, hvis De tager:
English: The foregoing presumes that the underlying disease state does not of itself modify the various elements in this profile.
Danish: Det føromtalte forudsætter, at den underliggende sygdomstilstand ikke i sig selv ændrer de forskellige elementer i profilen.
English: Serum creatinine μmol/l mg/10 ml
Danish: Serumkreatinin μmol/l mg/10 ml
English: - Dermatitis allergic
Danish: - Allergisk dermatitis
English: • Intravenous injections should be given very slowly
Danish: • Intravenøs injektion skal gives meget langsomt
English: Urinary excretion via glomerular filtration is the main route of elimination.
Danish: Urinudskillelse via glomerulær filtration er den primære eliminationsvej.
English: However, data on efficacy, posology and safety for these indications are limited.
Danish: Data vedrørende virkning, dosering og sikkerhed ved disse indikationer er dog begrænsede.
English: • effects on the immune system : allergic reactions
Danish: • Virkninger på immunsystemet: allergiske reaktioner
English: Renal clearance is equal to plasma clearance (110 to 116 mL/min).
Danish: Den renale clearance svarer til plasma-clearance (110116 ml/min).
English: Most of them were controlled versus placebo.
Danish: De fleste studier var placebokontrollerede.
English: • malaise with hypotension (low blood pressure), especially if the injection is given too quickly
Danish: • Alment ubehag med lavt blodtryk (hypotension), især hvis injektionen bliver givet for hurtigt.
English: Frequencies were defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), not know (can not be estimated from the available data).
Danish: Frekvenser er defineret som følger: meget almindelige (≥ 1/10), almindelige (≥ 1/100 til < 1/10), ikke almindelige (≥ 1/1.000 til < 1/100), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Tranexamic acid should be used throughout pregnancy only if the expected benefit justifies the potential risk.
Danish: Tranexamsyre bør kun anvendes under graviditet, hvis de forventede fordele opvejer den mulige risiko.
English: Simultaneous treatment with anticoagulants must take place under the strict supervision of a physician experienced in this field.
Danish: Samtidig behandling med antikoagulantia skal ske under nøje supervision af en læge med erfaring inden for området.
English: If you have a risk of having blood clots.
Danish: • Hvis De har risiko for at få blodpropper.
English: In vitro studies showed that high tranexamic dosages decreased the activity of complement.
Danish: In vitro-studier viser, at høje tranexamsyredoser nedsætter komplementaktiviteten.
English: Prevention and treatment of haemorrhages due to general or local fibrinolysis in adults and children from one year.
Danish: Forebyggelse og behandling af blødninger forårsaget af generel eller lokal fibrinolyse hos voksne og børn over 1 år.
English: - Diarrhoea - Vomiting - Nausea
Danish: - Diarré - Opkastning - Kvalme
English: While studied in very few patients, the limited data suggest that continuous infusion is preferable, since it would maintain therapeutic plasma concentration throughout surgery.
Danish: Selvom der kun er undersøgt hos meget få patienter, tyder de begrænsede data på, at kontinuerlig infusion er at foretrække, da det vil opretholde en terapeutisk plasmakoncentration under hele operationen.
English: Studied population was heterogenic in terms of age, surgery types, dosing schedules.
Danish: Den undersøgte population var heterogen, hvad angår alder, operationstype og dosering.
English: Signs and symptoms may include dizziness, headache, hypotension, and convulsions.
Danish: Tegn og symptomer kan omfatte svimmelhed, hovedpine, hypotension og kramper.
English: Talk to a doctor or pharmacist immediately.
Danish: Kontakt straks læge eller sundhedspersonale.
English: Elimination half-life of tranexamic acid is approximately 3 hours
Danish: Halveringstiden af tranexamsyre er ca. 3 timer.
English: Currently available data are limited and are described in section 5.1.
Danish: De foreliggende data er begrænsede og er beskrevet i pkt.
English: Adverse reactions are listed according to MedDRA primary system organ class.
Danish: Bivirkningerne er anført i henhold til MedDRA's primære systemorganklasser.
English: Before use of TXA, risk factors of thromboembolic disease should be considered.
Danish: Før administration af tranexamsyre skal risikofaktorer for tromboemboliske sygdomme vurderes.
English: Women of childbearing potential have to use effective contraception during treatment.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen.
English: Excretion of tranexamic acid is about 90% within the first 24 hours after intravenous administration of 10 mg/kg body weight.
Danish: Udskillelsen af tranexamsyre er ca. 90% inden for de første 24 timer efter intravenøs administration af 10 mg/kg.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktionstoksicitet.
English: There is a theoretical risk of increased thrombus-formation potential, such as with oestrogens.
Danish: Der er en teoretisk risiko for øget trombedannelse, for eksempel med østrogener.
English: Within each system organ class, adverse reactions are ranked by frequency.
Danish: Inden for hver enkelt systemorganklasse er bivirkningerne opstillet efter frekvens.
English: The ADRs reported from clinical studies and post-marketing experience are listed below according to system organ class.
Danish: Bivirkninger set i kliniske forsøg og efter markedsføring anføres nedenfor i henhold til systemorganklasse.
English: Disseminated intravascular coagulation
Danish: Dissemineret intravaskulær koagulation
English: 4.2 Posology and method of administration Posology Adults Unless otherwise prescribed, the following doses are recommended: 1.
Danish: Dosering Voksne Medmindre andet er ordineret, anbefales følgende dosering: 1.
English: Your doctor will decide the correct dose for you and how long you should take it.
Danish: Lægen vil bestemme Deres dosis, og hvor lang tid De skal behandles.
English: The activity of the tranexamic acid-plasmin complex on the activity on fibrin is lower than the activity of free plasmin alone.
Danish: Aktiviteten af tranexamsyre-plasmin-komplekset på aktiviteten af fibrin er lavere end aktiviteten af frit plasmin alene.
English: • are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6)
Danish: • er allergisk over for tranexamsyre eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: In coronary artery bypass graft (CABG) surgery, most of these cases were reported following intravenous (i.v.)
Danish: Ved koronararterie-bypass-operation (CABG) ses de fleste tilfælde efter intravenøs (i.v.)
English: There is insufficient clinical data on the use of tranexamic acid in pregnant women.
Danish: Der er utilstækkelige kliniske data fra anvendelse af tranexamsyre til gravide kvinder.
English: Fertility: There are no clinical data on the effects of Tranexamic acid on fertility.
Danish: Fertilitet Der foreligger ingen kliniske data om tranexamsyres virkning på fertilitet.
English: Pharmacotherapeutic group: Antihemorrhagics, Antifibrinolytics ATC code: B02AA02
Danish: Farmakoterapeutisk klassifikation: Hæmostatika, antifibrinolytika ATC-kode: B 02 AA 02
English: The efficacy, posology and safety of tranexamic acid in children undergoing cardiac surgery have not been fully established.
Danish: Virkning, dosering og sikkerhed af tranexamsyre til børn i forbindelse med hjertekirurgi er ikke fuldt klarlagt.
English: • have currently a disease leading to blood clots
Danish: • for tiden lider af en sygdom, hvor De får blodpropper.
English: Limited clinical of the use of tranexamic acid in different clinical haemorrhagic settings during the second and third trimesters did not identify deleterious effect for the foetus.
Danish: Begrænsede kliniske data fra anvendelse af tranexamsyre i forskellige kliniske blødningssituationer under andet og tredje trimester viste ikke skadelige virkninger på fosteret.
English: Characteristically, the haematological profile approximates to the following: reduced euglobulin clot lysis time; prolonged prothrombin time; reduced plasma levels of fibrinogen, factors V and VIII, plasminogen fibrinolysin and alpha-2 macroglobulin; normal plasma levels of P and P complex; i.e. factors II (prothrombin), VIII and X; increased plasma levels of fibrinogen degradation products; a normal platelet count.
Danish: Karakteristisk nærmer den hæmatologiske profil sig følgende: nedsat euglobulin clot-lyse-tid; forlænget protrombintid; nedsat plasmaniveau af fibrinogen, faktor V og VIII, plasminogenfibrinolysin og alfa-2 makroglobulin; normale plasmaniveauer af P og P-kompleks, dvs. faktor II (protrombin), VIII og X; øgede plasmaniveauer af fibrinogennedbrydningsprodukter; normal blodpladetælling.
English: Attention should be paid to possible visual disturbances including visual impairment, vision blurred, impaired colour vision and if necessary the treatment should be discontinued.
Danish: Der bør udvises opmærksomhed over for mulige synsforstyrrelser, herunder nedsat syn, sløret syn og påvirket farvesyn , og om nødvendigt skal behandlingen seponeres.
English: Your doctor will decide the correct dose for the child and how long he/she should take it.
Danish: Lægen vil bestemme den korrekte dosis, og hvor lang tid barnet skal behandles.
English: Due to the risk of cerebral oedema and convulsions, intrathecal and intraventricular injection and intracerebral application are not recommended.
Danish: På grund af risikoen for væskeansamling i hjernen og kramper anbefales intratekal og intraventrikulær injektion og intracerebral anvendelse ikke.
English: Tranexamic acid does not bind to serum albumin.
Danish: Tranexamsyre bindes ikke til serumalbumin.
English: The plasma protein binding of tranexamic acid is about 3% at therapeutic plasma levels and seems to be fully accounted for by its binding to plasminogen.
Danish: Tranexamsyres binding til plasmaproteiner er ca. 3% ved terapeutiske plasmaniveauer, og dette synes udelukkende at skyldes binding til plasminogen.
English: Patients with disseminated intravascular coagulation (DIC) should in most cases not be treated with tranexamic acid (see section 4.3).
Danish: Patienter med dissemineret intravaskulær koagulation (DIC) bør i de fleste tilfælde ikke behandles med tranexamsyre (se pkt.
English: With the use of the recommended lower doses of TXA, the incidence of post-operative seizures was the same as that in untreated patients.
Danish: Ved administration af de anbefalede lavere doser af tranexamsyre er hyppigheden af post-operative kramper på samme niveau som hos ubehandlede patienter.
English: 4.4 Special warnings and precautions for use The indications and method of administration indicated above should be followed strictly:
Danish: Indikationer og administration angivet ovenfor skal overholdes meget nøje:
English: Tranexamic acid has been detected in semen where it inhibits fibrinolytic activity but does not influence sperm migration.
Danish: Tranexamsyre er fundet i sæd, hvor den hæmmer fibrinolytisk aktivitet, men ikke påvirker spermatozomigration.
English: • have a condition called ‘consumption coagulopathy' where blood in the whole body starts to clot
Danish: • har en tilstand, der kaldes dissemineret intravaskulær koagulation, hvor blod i hele kroppen begynder at størkne.
English: If <Tranexamic acid - containing medicinal products> solution for injection is given to a child from one year, the dose will be based on the child's weight.
Danish: Hvis <lægemidler, der indeholder tranexamsyre> injektionsvæske gives til børn over 1 år, vil dosis blive udregnet efter barnets vægt.
English: Plasma concentrations increase in patients with renal failure.
Danish: Plasmakoncentrationen øges hos patienter med nyresvigt.
English: Intrathecal and intraventricular injection, intracerebral application (risk of cerebral oedema and convulsions)
Danish: Intratekal og intraventrikulær injektion, intracerebral applikation (risiko for cerebralt ødem og kramper).
English: It has been shown that convulsions tend to occur at higher frequency with increasing dose.
Danish: Det er blevet påvist, at kramper optræder hyppigere ved øget dosering.
English: Study results with tranexamic acid suggest reduced blood loss and reduced blood product requirements in paediatric cardiac surgery under cardiopulmonary bypass (CPB) where there is a high risk of haemorrhage, especially in cyanotic patients or patients undergoing repeat surgery.
Danish: Studieresultaterne for tranexamsyre tyder på nedsat blodtab og nedsat behov for blodprodukter ved hjertekirurgi på børn under kardiopulmonal bypass (KPB), hvor der er en høj risiko for blødning, især hos cyanotiske patienter og hos patienter, der opereres flere gange.
English: NAME OF THE MEDICINAL PRODUCT Tranexamic acid containing medicinal products [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN Lægemidler, der indeholder tranexamsyre [Se bilag I - Udfyldes nationalt]
English: A complex involving tranexamic acid, plasminogen is constituted; the tranexamic acid being linked to plasminogen when transformed into plasmin.
Danish: Et kompleks, der involverer tranexamsyre og plasminogen, dannes; tranexamsyre bindes til plasminogen, når det omdannes til plasmin.
English: - Hypersensitivity reactions including anaphylaxis
Danish: - Overfølsomhedsreaktioner herunder anafylaksi
English: • effects on the eyes : vision disturbances including impaired color vision
Danish: • Virkninger på øjnene: synsforstyrrelser, herunder ændret farvesyn
English: Alternatively, the antifibrinolytic action of the drug may be antagonised with thrombolytic drugs.
Danish: På den anden side kan den antifibrinolytiske virkning af lægemidlet antagoniseres med trombolytika.
English: • effects on the nervous system: convulsions
Danish: • Virkninger på nervesystemet: kramper
English: Peak plasma concentrations of tranexamic acid are obtained rapidly after a short intravenous infusion after which plasma concentrations decline in a multi-exponential manner.
Danish: Maksimal plasmakoncentration af tranexamsyre opnås hurtigt efter kortvarig intravenøs infusion, hvorefter plasmakoncentrationen falder på multi-eksponentiel måde.
English: <Tranexamic acid - containing medicinal products> must not be injected into a muscle.
Danish: <Lægemidler, der indeholder tranexamsyre> må ikke indsprøjtes i en muskel.
English: Tranexamic acid passes through the placenta.
Danish: Tranexamsyre passerer placenta.
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - udfyldes nationalt] {Navn og adresse} <{tlf.}> <{fax}> <{e-mail}>
English: For patient with mild to moderate renal impairment, the dosage of tranexamic acid should be reduced according to the serum creatinine level:
Danish: Hos patienter med let til moderat nedsat nyrefunktion skal dosis nedsættes i henhold til serumkreatinin:
English: Use in elderly No reduction in dosage is necessary unless there is evidence of renal failure.
Danish: Ældre Dosisnedsættelse er ikke nødvendig, medmindre der er tegn på nedsat nyrefunktion.
English: If you a kidney problem, your dose of tranexamic acid will be reduced according to a test performed on your blood (serum creatinine level).
Danish: Hvis De har nyreproblemer, vil dosis af tranexamsyre blive nedsat i henhold til resultatet af en blodprøve (serumkreatinin).
English: Tranexamic acid should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis (See section 4.5.
Danish: Tranexamsyre bør administreres med forsigtighed til patienter i behandling med orale kontraceptiva på grund af øget risiko for tromboser (se pkt.
English: injection of tranexamic acid in high doses.
Danish: injektion af høje doser tranexamsyre.
English: Visual disturbances
Danish: Synsforstyrrelser
English: In patients with a history of thromboembolic diseases or in those with increased incidence of thromboembolic events in their family history (patients with a high risk of thrombophilia), Tranexamic acid solution for injection should only be administered if there is a strong medical indication after consulting a physician experienced in hemostaseology and under strict medical supervision (see section 4.3).
Danish: Hos patienter med tromboemboliske sygdomme i anamnesen eller med øget familiær forekomst af tromboemboliske hændelser (patienter med høj risiko for trombofili) bør tranexamsyre-injektionsvæske kun anvendes, hvis der er tale om en stærk medicinsk indikation ifølge vurdering af en læge med særlig kendskab til hæmostasiologi og kun under nøje overvågning (se pkt.
English: Common (may affect up to 1 in 10 users) • effects on the stomach and intestines: nausea, vomiting, diarrhoea
Danish: Almindelige (det sker hos mellem 1 og 10 ud af 100 patienter) • Virkninger i maven og tarmene: kvalme, opkastning, diaré
English: If tranexamic acid is given it must be restricted to those in whom there is predominant activation of the fibrinolytic system with acute severe bleeding.
Danish: Hvis tranexamsyre gives, skal det forbeholdes patienter, som primært har aktivering af det fibrinolytiske system med akut alvorlig blødning.
English: Medicinal products that act on haemostasis should be given with caution to patients treated with tranexamic acid.
Danish: Lægemidler, der påvirker hæmostasen, bør gives med forsigtighed til patienter i behandling med tranexamsyre.
English: Following administration of an intravenous injection of 10 mg/kg to 12 pregnant women, the concentration of tranexamic acid in serum ranged 10-53 μg/mL while that in cord blood ranged 4-31 μg/mL.
Danish: Efter intravenøs injektion af 10 mg/kg til 12 gravide kvinder lå koncentrationen af tranexamsyre i serum i intervallet 10-53 µg/ml, mens den i navlestrengsblod lå mellem 4 og 31 µg/ml.
English: Tranexamic acid diffuses rapidly into joint fluid and the synovial membrane.
Danish: Tranexamsyre diffunderer hurtigt ud i ledvæsken og synovialmembranen.
English: The most adapted dosing schedule appeared to be: - first bolus of 10 mg/kg after induction of anaesthesia and prior to skin incision, - continuous infusion of 10 mg/kg/h or injection into the CPB pump prime at a dose adapted on the CPB procedure, either according to a patient weight with a dose of 10 mg/kg dose, either according to CPB pump prime volume, last injection of 10 mg/kg at the end of CPB.
Danish: Den hyppigst brugte dosering synes at være: - Første bolus på 10 mg/kg efter anæstesiinduktion og før incision af huden - Kontinuerlig infusion af 10 mg/kg/time eller injektion i hjertelungemaskinens primer med en dosis tilpasset KPB-proceduren, enten i henhold til patientens vægt med 10 mg/kg/dosis, eller i henhold til hjertelungemaskinens volumen, sidste injektion på 10 mg/kg ved afslutningen af
English: <Tranexamic acid - containing medicinal products> is used in adults and children above one year of age for the prevention and treatment of bleeding due to a process that inhibits blood clotting called fibrinolysis.
Danish: <Lægemidler, der indeholder tranexamsyre> anvendes til voksne og børn over 1 år til forebyggelse og behandling af blødning forårsaget af en proces i kroppen, som kaldes fibrinolyse, og som nedsætter blodets evne til at størkne.
English: Tranexamic acid is excreted in human milk.
Danish: Amning Tranexamsyre udskilles i human mælk.
English: <[See Annex I - To be completed nationally]>
Danish: <[Se bilag I - Udfyldes nationalt]>
English: The concentration of tranexamic acid in a number of other tissues is a fraction of that observed in the blood (breast milk, one hundredth; cerebrospinal fluid, one tenth; aqueous humor, one tenth).
Danish: Koncentrationen af tranexamsyre i en række andre væv er lavere end i blodet (i mælk 1/100; i cerebrospinalvæske 1/10; i kammervæske 1/10).
English: Annex III Summary of Product Characteristics and Package Leaflet
Danish: Bilag III Produktresume, etikettering og indlægsseddel
English: • If you have had blood in your urine <Tranexamic acid - containing medicinal products> it may be lead to urinary tract obstruction.
Danish: • Hvis De har haft blod i urinen, kan <lægemidler, der indeholder tranexamsyre> forårsage tilstoppede urinveje.
English: Adverse reactions reported are presented in table below.
Danish: Rapporterede bivirkninger fremgår af nedenstående tabel.
English: If you think any of these apply to you, or if you are in any doubt at all, tell your doctor before taking <Tranexamic acid - containing medicinal products>.
Danish: Hvis De mener, at noget af ovenstående gælder for Dem, eller hvis De overhovedet er i tvivl, så rådfør Dem med Deres læge, inden De får <lægemidler, der indeholder tranexamsyre>.
English: - Malaise with hypotension, with or without loss of consciousness (generally following a too fast intravenous injection, exceptionally after oral administration)
Danish: - Utilpashed med hypotension med eller uden bevidsthedstab (normalt som følge af for hurtig intravenøs injektion, undtagelsesvist efter oral administration) - Arterie- eller veneemboli et hvilket som helst sted
English: Method of administration The administration is strictly limited to slow intravenous injection.
Danish: Administration Tranexamsyre skal udelukkende administreres som langsom intravenøs injektion.
English: Uncommon (may affect 1 to 10 in 1000 users) • effects on the skin problems : rash
Danish: Ikke almindelige (det sker hos mellem 1 og 10 ud af 1.000 patienter) • Virkninger på huden: udslæt
English: No specific PK study has been conducted in children.
Danish: Der er ikke udført specifikke farmakokinetiske studier hos børn.
English: Your doctor must use the minimal dose possible to avoid convulsions following treatment with <Tranexamic acid - containing medicinal products>
Danish: Lægen skal give den lavest mulige dosis for at undgå kramper i forbindelse med behandling med <lægemidler, der indeholder tranexamsyre>.
English: Epileptogenic activity has been observed in animals with intrathecal use of tranexamic acid.
Danish: Epileptogen aktivitet er set hos dyr efter intratekal administration af tranexamsyre.
English: If you are given more <Tranexamic acid - containing medicinal products> than the recommended dose you may experience a transitory blood pressure lowering.
Danish: Hvis De har fået for meget <lægemidler, der indeholder tranexamsyre> Hvis De har fået mere end den anbefalede dosis af <lægemidler, der indeholder tranexamsyre>, kan De opleve forbigående blodtryksfald.
English: • blood clots
Danish: • Blodpropper
English: • medicines that prevent blood clotting, called thrombolytic medicines
Danish: • medicin, der forhindrer blodet i at størkne, såkaldte trombolytika