FrancophonIA/ELRC3.0 huggingface dataset:
English: The per-protocol efficacy analysis includes 37 surgeries performed in 27 patients between 17 and 57 years of age undergoing major or minor surgical, dental or other surgical invasive procedures.
Danish: RIXUBIS' sikkerhed og virkning i et perioperativt miljø blev vurderet i et ikke-kontrolleret, prospektivt, åbent, fase 3-multicenterstudie med tidligere behandlede mandlige patienter med svær og moderat svær hæmofili B. Effektanalysen i per-protokol-populationen omfatter 37 kirurgiske indgreb udført på 27 patienter mellem 17 og 57 år, der fik foretaget større eller mindre kirurgiske, dentale eller andre invasive procedurer.
English: Kidney disorders (nephrotic syndrome) have been reported following high doses of Factor IX in haemophilia B patients with factor IX inhibitors and a history of allergic reactions.
Danish: Efter høje doser af faktor IX er der rapporteret nyresygdomme (nefrotisk syndrom) hos hæmofili B-patienter, der har udviklet faktor IX-inhibitorer, og som tidligere har haft allergiske reaktioner.
English: What RIXUBIS is and what it is used for What you need to know before you use RIXUBIS How to use RIXUBIS
Danish: Det skal du vide, før du begynder at bruge RIXUBIS Sådan skal du bruge RIXUBIS Bivirkninger
English: Week 13 All (N=10)
Danish: Uge 13 Alle (N=10)
English: Week 5 All (N=11)
Danish: Uge 5 Alle (N=11)
English: Week 13 All (N=11)
Danish: Uge 13 Alle (N=11)
English: 1 vial: 250 IU nonacog gamma, approx. 50 IU/ml after reconstitution with 5 ml solvent.
Danish: 1 hætteglas: 250 IE nonacog gamma, ca. 50 IE/ml efter rekonstitution med 5 ml solvens.
English: RIXUBIS 250 IU powder for injection nonacog gamma
Danish: RIXUBIS 250 IE pulver til injektion nonacog gamma i.v.-anvendelse
English: RIXUBIS 500 IU powder for injection nonacog gamma
Danish: RIXUBIS 500 IE pulver til injektion nonacog gamma i.v.-anvendelse
English: 1 vial: 3000 IU nonacog gamma, approx. 600 IU/ml after reconstitution with 5 ml solvent.
Danish: 1 hætteglas: 3000 IE nonacog gamma, ca. 600 IE/ml efter rekonstitution med 5 ml solvens.
English: Median (range) Cmax (IU/dL) Mean±SD
Danish: Gennemsnit ±SD Median (interval) Halveringstid (timer) Gennemsnit ±SD Median (interval) Cmax (IE/dl)
English: 1 vial: 2000 IU nonacog gamma, approx. 400 IU/ml after reconstitution with 5 ml solvent.
Danish: 1 hætteglas: 2000 IE nonacog gamma, ca. 400 IE/ml efter rekonstitution med 5 ml solvens.
English: (inhibitors) against your medicine, as inhibitors may develop together with allergies.
Danish: Lægen kan også tage en blodprøve for at undersøge, om du har udviklet neutraliserende antistoffer (inhibitorer), der hæmmer aktiviteten af RIXUBIS, da inhibitorer kan udvikles sammen med allergier.
English: RIXUBIS 3000 IU powder for injection nonacog gamma
Danish: RIXUBIS 3000 IE pulver til injektion nonacog gamma i.v.-anvendelse
English: 1 vial: 500 IU nonacog gamma, approx. 100 IU/ml after reconstitution with 5 ml solvent.
Danish: 1 hætteglas: 500 IE nonacog gamma, ca. 100 IE/ml efter rekonstitution med 5 ml solvens.
English: RIXUBIS 250 IU powder and solvent for solution for injection One vial contains nominally 250 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 50 IU/ml after reconstitution with 5 ml solvent.
Danish: RIXUBIS 250 IE pulver og solvens til injektionsvæske, opløsning Et hætteglas indeholder nominelt 250 IE nonacog gamma, rekombinant human koagulationsfaktor IX (rDNA), svarende til en koncentration på 50 IE/ml efter rekonstitution med 5 ml solvens.
English: RIXUBIS 500 IU powder and solvent for solution for injection One vial contains nominally 500 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 100 IU/ml after reconstitution with 5 ml solvent.
Danish: RIXUBIS 500 IE pulver og solvens til injektionsvæske, opløsning Et hætteglas indeholder nominelt 500 IE nonacog gamma, rekombinant human koagulationsfaktor IX (rDNA), svarende til en koncentration på 100 IE/ml efter rekonstitution med 5 ml solvens.
English: RIXUBIS 1000 IU powder for injection nonacog gamma
Danish: RIXUBIS 1000 IE pulver til injektion nonacog gamma i.v.-anvendelse
English: 1 vial: 1000 IU nonacog gamma, approx. 200 IU/ml after reconstitution with 5 ml solvent.
Danish: 1 hætteglas: 1000 IE nonacog gamma, ca. 200 IE/ml efter rekonstitution med 5 ml solvens.
English: RIXUBIS 250 IU powder and solvent for solution for injection nonacog gamma (recombinant human coagulation factor IX)
Danish: RIXUBIS 250 IE pulver og solvens til injektionsvæske, opløsning nonacog gamma (rekombinant human koagulationsfaktor IX)
English: RIXUBIS 3000 IU powder and solvent for solution for injection One vial contains nominally 3000 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 600 IU/ml after reconstitution with 5 ml solvent.
Danish: RIXUBIS 3.000 IE pulver og solvens til injektionsvæske, opløsning Et hætteglas indeholder nominelt 3.000 IE nonacog gamma, rekombinant human koagulationsfaktor IX (rDNA), svarende til en koncentration på 600 IE/ml efter rekonstitution med 5 ml solvens.
English: RIXUBIS 500 IU powder and solvent for solution for injection nonacog gamma (recombinant human coagulation factor IX)
Danish: RIXUBIS 500 IE pulver og solvens til injektionsvæske, opløsning nonacog gamma (rekombinant human koagulationsfaktor IX)
English: RIXUBIS 2000 IU powder for injection nonacog gamma
Danish: RIXUBIS 2000 IE pulver til injektion nonacog gamma i.v.-anvendelse
English: RIXUBIS 3000 IU powder and solvent for solution for injection nonacog gamma (recombinant human coagulation factor IX)
Danish: RIXUBIS 3000 IE pulver og solvens til injektionsvæske, opløsning nonacog gamma (rekombinant human koagulationsfaktor IX)
English: RIXUBIS 2000 IU powder and solvent for solution for injection nonacog gamma (recombinant human coagulation factor IX)
Danish: RIXUBIS 2000 IE pulver og solvens til injektionsvæske, opløsning nonacog gamma (rekombinant human koagulationsfaktor IX)
English: RIXUBIS 1000 IU powder and solvent for solution for injection One vial contains nominally 1000 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 200 IU/ml after reconstitution with 5 ml solvent.
Danish: RIXUBIS 1.000 IE pulver og solvens til injektionsvæske, opløsning Et hætteglas indeholder nominelt 1.000 IE nonacog gamma, rekombinant human koagulationsfaktor IX (rDNA), svarende til en koncentration på 200 IE/ml efter rekonstitution med 5 ml solvens.
English: Excipient related considerations
Danish: Hjælpestofrelaterede overvejelser
English: RIXUBIS 1000 IU powder and solvent for solution for injection nonacog gamma (recombinant human coagulation factor IX)
Danish: RIXUBIS 1000 IE pulver og solvens til injektionsvæske, opløsning nonacog gamma (rekombinant human koagulationsfaktor IX)
English: Median (range)
Danish: = legemsvægt (kg)
English: RIXUBIS 2000 IU powder and solvent for solution for injection One vial contains nominally 2000 IU nonacog gamma, recombinant human coagulation factor IX (rDNA), corresponding to a concentration of 400 IU/ml after reconstitution with 5 ml solvent.
Danish: RIXUBIS 2.000 IE pulver og solvens til injektionsvæske, opløsning Et hætteglas indeholder nominelt 2.000 IE nonacog gamma, rekombinant human koagulationsfaktor IX (rDNA), svarende til en koncentration på 400 IE/ml efter rekonstitution med 5 ml solvens.
English: Median (range) Mean residence time (hr) Mean±SD
Danish: Gennemsnit ±SD Median (interval) Gennemsnitlig opholdstid (timer)
English: Careful aspiration prior to administration is recommended.
Danish: Omhyggelig aspiration før administration anbefales.
English: This medicine contains two active substances:
Danish: Lægemidlet indeholder to aktive stoffer:
English: Not known: frequency cannot be estimated from the available data
Danish: Ikke kendt: hyppigheden kan ikke estimeres ud fra forhåndenværende data
English: SN: {number} <NN: {number} >
Danish: NN: {nummer}
English: There is no experience of the use of articaine in pregnant women, except during childbirth.
Danish: Der er ingen erfaring med brugen af articain hos gravide kvinder, undtagen under fødslen.
English: Renal elimination of unchanged articaine accounted for only about 2% of total elimination.
Danish: Renal elimination af uændret articain tegnede sig kun for omkring 2% af den samlede elimination.
English: The rate of injection should be very slow (1 ml/min).
Danish: Injektionshastigheden skal være meget langsom (1 ml/min).
English: 4.5 Interaction with other medicinal products and other forms of interaction
Danish: 4.5 Interaktioner med andre lægemidler og andre former for interaktion
English: • are more than 70 years old.
Danish: • hvis du er over 70 år
English: 4.8 Undesirable effects a) Summary of the safety profile
Danish: 4.8 Bivirkninger a) Sammendrag af sikkerhedsprofilen
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan, hvis relevant, efterfølgende opdateres af medlemsstatens kompetente myndigheder i samarbejde med referencemedlemsstaten i henhold til procedurerne i afsnit III, kapitel 4, i direktiv 2001/83/EF.
English: The necessary dosage must be determined on an individual basis.
Danish: Den påkrævede dosis skal bestemmes individuelt.
English: The higher risk of bleeding is more associated with the procedure, rather than with the medicine.
Danish: Den højere blødningsrisiko er i højere grad forbundet med proceduren end med lægemidlet.
English: • X is usually used for simple and short dental procedures
Danish: • X bruges normalt til simple og korte tandlægebehandlinger
English: Due to articaine:
Danish: På grund af articain:
English: These medicinal products are 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]>
Danish: Disse lægemidler er godkendt i EØS's medlemslande under følgende navne: <{Medlemslandets navn}> <{Lægemidlets navn}> <{Medlemslandets navn}> <{Lægemidlets navn}> [Se bilag I - Udfyldes nationalt]
English: Binding to γ-globulin (8.6-23.7%) was much lower.
Danish: Binding til γ-globulin (8,6-23,7 %) var meget lavere.
English: It is not likely that you will be given too much of this injection but if you should begin to feel unwell, tell your dentist.
Danish: Det er ikke sandsynligt, at du får for meget af denne indsprøjtning, men såfremt du begynder at føle dig utilpas, skal du sige det til tandlægen.
English: • heart attack in the last 3 to 6 months;
Danish: • hvis du har haft et hjerteanfald inden for de seneste 3 til 6 måneder
English: In case of relative overdose, patients generally present symptoms within the first minutes.
Danish: I tilfælde af relativ overdosering, udviser patienten generelt symptomer inden for de første minutter.
English: The pKa of articaine has been estimated at 7.8.
Danish: Articains pKa-værdi er blevet estimeret til 7,8.
English: The safety profile was similar in children and adolescents from 4 to 18 years old compared to adults.
Danish: Sikkerhedsprofilen var ens hos børn og unge fra 4 til 18 år sammenlignet med voksne.
English: 70 or more
Danish: 70 eller over
English: Since this hydrolysis is very fast, about 90% of articaine is inactivated by this way.
Danish: Da denne hydrolyse er meget hurtig, inaktiveres ca. 90 % af articain på denne måde.
English: No difference was observed in pharmacodynamic properties between the adult and the paediatric population.
Danish: Der blev ikke observeret nogen forskel i farmakodynamiske egenskaber mellem den voksne population og den pædiatriske population.
English: • extremely good mood (euphoria)
Danish: • ekstremt godt humør (eufori)
English: However, these findings are of little relevance to its clinical use as acute administration.
Danish: Disse resultater har dog ringe relevans for dets kliniske anvendelse som akut indgivelse.
English: Mechanism of action and pharmacodynamic effects:
Danish: Virkningsmekanisme og farmakodynamiske virkninger:
English: • increased sensitivity to heat
Danish: • øget følsomhed over for varme
English: Serious adverse reactions are generally systemic.
Danish: Alvorlige bivirkninger er generelt systemiske.
English: They may also result from hypersensitivity, idiosyncrasy, or diminished tolerance by patient.
Danish: De kan også skyldes overfølsomhed, idiosynkrasi eller nedsat tolerance hos patienten.
English: Unused solution must be discarded.
Danish: Ubrugt opløsning skal kasseres.
English: Depending on the kind of dental procedure performed, the dentist will choose between the two medicines:
Danish: Afhængigt af hvilken tandlægebehandling, der udføres, vil tandlægen vælge mellem de to lægemidler:
English: Adrenaline passes into breast milk but also has a short half-life.
Danish: Adrenalin passerer ind i modermælken, men har også en kort halveringstid.
English: While you are in your dentist's office, your dentist will carefully follow the effects of X / Y.
Danish: Mens du er på tandlægeklinikken, vil din tandlæge nøje følge virkningen af X/Y.
English: Only physicians or dentists are trained to use X/Y.
Danish: Kun læger og tandlæger er uddannede til at bruge X/Y.
English: Elderly patients:
Danish: Ældre patienter:
English: • Y is more adapted to procedures lasting longer or with possible significant bleeding.
Danish: • Y er mere tilpasset behandlinger, der varer længere eller med mulig væsentlig blødning.
English: No data are available.
Danish: Der er ingen tilgængelige data.
English: (tricyclic antidepressants).
Danish: (tricykliske antidepressiva).
English: X / Y is a clear and colourless solution.
Danish: X/Y er en klar og farveløs opløsning.
English: Your dentist will choose between X and Y, and determine the appropriate dose taking into account your age, your weight, your general health and the dental procedure.
Danish: Din tandlæge vil vælge mellem X og Y og bestemme den passende dosis under hensyntagen til din alder, din vægt, dit generelle helbred og tandlægebehandlingen.
English: Your dentist or doctor will decide if you can use X / Y during pregnancy.
Danish: Din tandlæge eller læge vil beslutte, om du kan bruge X/Y under graviditet.
English: Within 24 hours, approximately 57% (68 mg) and 53% (204 mg) of the dose was eliminated in the urine.
Danish: Inden for 24 timer blev ca. 57 % (68 mg) og 53 % (204 mg) af dosis elimineret i urinen.
English: More than 50% of the dose was eliminated in the urine, 95% as articainic acid, within 8 hours of administration.
Danish: Mere end 50 % af dosis blev elimineret i urinen, 95 % som articainsyre, inden for 8 timer efter administration.
English: Adrenaline exhibits sympathomimetic effects.
Danish: Adrenalin udviser sympatomimetiske virkninger.
English: d) Paediatric population
Danish: d) Pædiatrisk population
English: Very little articaine was detected in plasma from 12 to 24 hours following injection.
Danish: Der blev påvist meget lave articainkoncentrationer i plasma fra 12 til 24 timer efter injektionen.
English: Children should be given doses commensurate with age and weight.
Danish: Børn skal gives doser i forhold til deres alder og vægt.
English: So, patients should not leave the dental office until they recover their abilities (generally within 30 minutes) following the dental procedure.
Danish: Patienter bør derfor ikke forlade tandlægeklinikken, før de har generhvervet deres evner (normalt inden for 30 minutter) efter tandbehandlingen.
English: Due to adrenaline:
Danish: På grund af adrenalin:
English: The reported adverse reactions come from spontaneous reporting, clinical studies and literature.
Danish: De indberettede bivirkninger stammer fra spontan indberetning, kliniske studier og litteraturen.
English: These medicines may intensify the effects of adrenaline.
Danish: Disse lægemidler kan intensivere virkningerne af adrenalin.
English: Most cases of paresthesia reported following dental treatment are transient and resolve within days, weeks or months.
Danish: De fleste tilfælde af paræstesi, der er indberettet efter tandlægebehandling er forbigående og forsvinder inden for dage, uger eller måneder.
English: It also decreases bleeding during surgery.
Danish: Det nedsætter også blødning under operationen.
English: • simultaneously taking some medicines for the treatment of depression and Parkinson's disease
Danish: • hvis du samtidig tager nogle lægemidler til behandling af depression og Parkinsons sygdom
English: It is not usually necessary to suspend breast-feeding for short-term use, starting from 5 hours following anesthesia.
Danish: Det er normalt ikke nødvendigt at afbryde amning ved kortvarig brug, startende fra 5 timer efter anæstesi.
English: Local and loco-regional anaesthesia in dental procedures.
Danish: Lokal og lokal-regional anæstesi ved tandlægeprocedurer.
English: The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation.
Danish: Den mængde, der skal injiceres, skal bestemmes ud fra barnets alder og vægt og operationens omfang.
English: Hypotension (with possible circulatory collapse) Uncommon Hypertension Rare
Danish: Hypotension (med muligt kredsløbskollaps) Ikke almindelig Hypertension Sjælden
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your dentist or doctor for advice before using 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 tandlæge eller læge til råds, før du bruger dette lægemiddel.
English: The table below illustrates the maximum recommended dose:
Danish: Nedenstående tabel viser den maksimale anbefalede dosis:
English: Concomitant use of sedatives to reduce patient anxiety:
Danish: Samtidig brug af sedativer for at reducere patientens angst:
English: • serious problems with your liver
Danish: • hvis du har alvorlige problemer med din lever
English: • double vision, temporary blindness
Danish: • dobbeltsyn, midlertidig blindhed
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of these medicines.
Danish: Du kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger du kan hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: (see section 4.5)
Danish: (angivet i punkt 6).
English: Appropriate precautions should be taken in all patients with porphyria, as this medicinal product can trigger porphyria.
Danish: Der bør træffes passende forholdsregler for alle patienter med porfyri, da dette lægemiddel kan udløse porfyri.
English: Very rare side effects: may affect up to 1 in 10,000 people: • persistent loss of sensitivity, extended numbness and loss of taste
Danish: Meget sjældne bivirkninger: kan påvirke op til 1 ud af 10.000 personer: • vedvarende tab af følesans, forlænget følelsesløshed og tab af smagssans
English: It is especially important to tell your dentist if you are taking any of the following medicines:
Danish: Det er især vigtigt at fortælle det til din tandlæge, hvis du tager nogen af følgende lægemidler:
English: These adverse reactions are, in general, dose-related.
Danish: Disse bivirkninger er generelt dosisrelaterede.
English: If any sympathomimetic vasopressor has been used within 24 hours, the planned dental treatment should be postponed.
Danish: Hvis der er anvendt sympatomimetisk vasopressor inden for 24 timer, bør den planlagte tandbehandling udsættes.
English: • articaine, a local anaesthetic which prevents pain, and
Danish: • articain, et lokalbedøvelsesmiddel, der forhindrer smerte, og
English: Interactions requiring precautions for use:
Danish: Interaktioner, der kræver forsigtighedsregler:
English: Patient body weight (kg)
Danish: Patientens legemsvægt (kg)
English: However, accidental soft tissue injury was observed more frequently, especially in 3 to 7 year old children, due to the prolonged soft tissue anaesthesia.
Danish: Der blev dog hyppigere observeret utilsigtet bløddelslæsion, især hos 3- til 7-årige børn, på grund af den forlængede bløddelsanæstesi.
English: Preclinical data reveal no special hazard for humans at therapeutic doses, based on conventional studies of safety pharmacology, chronic toxicity, reproductive toxicity and genotoxicity.
Danish: Prækliniske data viser ingen særlig risiko for mennesker ved terapeutiske doser, baseret på konventionelle studier af sikkerhedsfarmakologi, kronisk toksicitet, reproduktionstoksicitet og genotoksicitet.
English: • metallic taste, taste disturbance or loss of taste function
Danish: • metallisk smag, smagsforstyrrelse eller tab af smagssans
English: The dose must also be reduced in case of hypoxia, hyperkalaemia and metabolic acidosis.
Danish: Dosis skal også reduceres i tilfælde af hypoksi, hyperkaliæmi og metabolisk acidose.
English: There is a risk of adrenergic toxicity.
Danish: Der er en risiko for adrenerg toksicitet.
English: In the event of inadvertent intravascular administration in the mother, adrenaline can reduce uterine perfusion.
Danish: I tilfælde af utilsigtet intravaskulær administration hos moderen kan adrenalin reducere den uterine perfusion.
English: • increased amount of blood in a part of the body leading to congestion of blood vessels
Danish: • øget mængde blod i en del af kroppen, der fører til overbelastning af blodkar
English: • a combination of drooping of the eyelid and constriction of the pupil (Horner's syndrome) These side effects happen rarely (may affect up to 1 in 1,000 people).
Danish: • en kombination af hængende øjenlåg og indsnævring af pupillen (Horners syndrom) Disse bivirkninger forekommer sjældent (kan påvirke op til 1 ud af 1.000 personer).
English: Store below 25°C.
Danish: Opbevares ved temperaturer under 25 ºC.
English: This medicinal product must be used with special caution in patients with the following disorders and postponement of dental surgery should be considered if the condition is severe and/or unstable.
Danish: Dette lægemiddel skal anvendes med særlig forsigtighed til patienter med følgende lidelser, og udsættelse af tandkirurgi bør overvejes, hvis tilstanden er alvorlig og/eller ustabil.
English: Not known Local / Regional hyperaemia Vasodilatation
Danish: Lokal/regional hyperæmi Vasodilatation Vasokonstriktion
English: This medicinal product must be used with caution in patients with the following disorders:
Danish: Dette lægemiddel skal bruges med forsigtighed til patienter med følgende lidelser:
English: Infiltration and perineural use.
Danish: Infiltration og perineural brug.
English: Biotransformation: Articaine is subject to hydrolysis of its carboxyl group by unspecific esterases in the tissue and in blood.
Danish: Biotransformation: Articain er underlagt hydrolyse af dets carboxylgruppe af uspecifikke esteraser i vævet og blodet.
English: doses of up to 20 mg/kg in rats and 12.5 mg/kg in rabbits.
Danish: doser på op til 20 mg/kg hos rotter og 12,5 mg/kg hos kaniner.
English: Avoid eating, included chewing-gum, until normal sensation is restored because there is a risk that you may bite your lips, cheeks or tongue, especially in children.
Danish: Undgå at spise, herunder at tygge tyggegummi, indtil du har genvundet normal følesans, da der er risiko for at bide sig selv i læben, kinden eller tungen, især hos børn.
English: Special precautions for disposal and other handling
Danish: Særlige forholdsregler for bortskaffelse og anden håndtering
English: Adrenaline, as vasoconstrictor, acts directly on both α- and β-adrenergic receptors; β-adrenergic effects predominate.
Danish: Adrenalin, som vasokonstriktor, virker direkte på både α- og β-adrenerge receptorer; β-adrenerge virkninger er fremherskende.