FrancophonIA/ELRC3.0 huggingface dataset:
English: • Events related to the nervous system (e.g. epileptic seizure, convulsion, speech disorder,
Danish: ● Bivirkninger relateret til nervesystemet (f.eks. epileptiske anfald, kramper, taleforstyrrelser,
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof,eller over for et eller flere af hjælpestofferne anført i pkt.
English: Arrhythmias (e.g. AV block, atrial fibrillation/flutter, ventricular tachycardia/fibrillation, electromechanical dissociation (EMD)), cardiac arrest, cardiogenic shock and reinfarction
Danish: Arytmier (f.eks. AV-blok, atrieflimren/flagren, ventrikulær takykardi/ventrikelflimren, elektromekanisk dissociation (EMD)), hjertestop, kardiogent shock og reinfarkt.
English: As with other thrombolytic agents, recurrent ischaemia/angina, hypotension and heart failure/pulmonary oedema have been reported frequently as sequelae of myocardial infarction and/or thrombolytic administration.
Danish: Som ved andre trombolytiske midler er recidiverende iskæmi/angina, hypotension og hjerteinsufficiens/lungeødem rapporteret hyppigt som følge af myokardieinfarkt og/eller trombolytisk behandling.
English: It is strongly recommended that antiarrhythmic therapy for bradycardia and/or ventricular tachyarrhythmias (e.g. ventricular tachycardia or fibrillation) be available when reteplase is administered.
Danish: Adgang til antiarytmisk terapi for bradykardi og/eller ventrikulær takyarytmier (f.eks. ventrikulær tarkykardi eller flimren) er stærkt anbefalet ved administration af reteplase.
English: Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjordur Iceland.
Danish: Reykjavikurvegi 76-78 220 Hafnarfjordur Island
English: Cardiovascular events can be life-threatening or cause death.
Danish: Virkninger på hjerte og kredsløb kan være livstruende eller forårsage døden.
English: In two clinical trials aiming primarily at coronary artery patency (RAPID I and II) reteplase was associated with higher early patency rates (primary efficacy criterion), as well as with a lower incidence of heart failure (secondary efficacy criterion) than alteplase (3 hour and "accelerated" dosage regimens).
Danish: II), som primært målte den passable tilstand af koronararterierne, viste, at reteplase behandling er forbundet med et højere tidligt passabel tilstands niveau (primær effekt kriterie), så vel som en lavere incidens af hjertesvigt (sekundær effekt kriterie) end alteplase (3 timer og ”accelererede” dosis regimer).
English: • if you have an ulcer in the stomach or small intestine.
Danish: • hvis De har sår i maven eller tarmen
English: Caution should be employed when used with other medicinal products affecting haemostasis such as heparin, low-molecular-weight heparins, heparinoids, oral anticoagulants and antiplatelet agents other than acetylsalicylic acid, such as dipyridamole, ticlopidine, clopidogrel or glycoprotein IIb/IIIa receptor antagonists.
Danish: Det er lægemidler såsom heparin, lavmolekylære hepariner, heparinoider, orale antikoagulantia og antithrombocyt midler udover acetylsalicylsyre, såsom dipyridamol, ticlopidin, clopidogrel eller glycoprotein IIb/IIIa receptor antagonister.
English: Mitral regurgitation, pulmonary embolism, other systemic embolism/cerebral embolism and ventricular septal defect
Danish: Mitralklap-regurgitation, lungeemboli, andre systemiske embolier/cerebral emboli, ventrikelseptumdefekt.
English: • Abnormal heart beats (arrhythmias), cardiac arrest, circulatory collapse or another heart attack may occur
Danish: • Abnorm hjerterytme (arytmier), hjertestop, kredsløbskollaps eller et nyt hjerteanfald
English: The risk of intracranial bleeding and fatal intracranial bleeding increases with increasing age.
Danish: Risikoen for intrakraniel blødning og fatal intrakraniel blødning stiger med stigende alder. Blodtransfusion var sjældent påkrævet.
English: • if you have a brain tumour or a malformed blood vessel or a vessel wall dilatation (aneurysm) in the brain.
Danish: • hvis De har en hjernetumor, et misdannet blodkar eller en udvidelse af en karvæg (aneurisme) i hjernen
English: Dosage of Rapilysin
Danish: Dosering af Rapilysin
English: If the solution is not clear and colourless it should be thrown away.
Danish: Hvis opløsningen ikke er klar og farveløs skal den bortkastes.
English: At present, insufficient data in patients with a diastolic blood pressure > 100 mmHg prior to thrombolytic therapy are available for reteplase.
Danish: På nuværende tidspunkt er der ikke tilstrækkelige data, omhandlende patienter i reteplase behandling, med et diastolisk blodtryk > 100 mmHg før trombolytisk behandling.
English: With the reconstitution spike and syringe still attached to the vial, swirl the vial gently to dissolve the Rapilysin 10 U powder.
Danish: Med rekonstitueringsnålen og injektionssprøjten fastgjort til hætteglasset, vendes hætteglasset forsigtigt for at opløse Rapilysin 10 E pulveret.
English: Death or permanent disability are not uncommon in patients who have a stroke (including bleeding in the brain) or other serious bleeding problem.
Danish: Død eller blivende handicap er ikke ualmindelige hos patienter, som har et slagtilfælde (inkl.
English: In the patients who fail to respond to these conservative measures, judicious use of transfusion products may be indicated.
Danish: Velovervejet brug af transfusionsprodukter kan være indiceret hos patienter, som ikke responderer på denne konservative behandling.
English: Intravenous use Read the package leaflet before use.
Danish: Intravenøs anvendelse Læs indlægssedlen inden brug
English: Powder and solvent for injection (contains 2x [0.56 g of powder in a vial and 10 ml solvent in a prefilled syringe with reconstitution spike and needle])
Danish: Pulver og solvens til injektionsvæske (indeholder 2x [0,56 g pulver i et hætteglas og 10 ml solvens i en fyldt injektionssprøjte med rekonstitueringsnåle og nåle])
English: Reteplase activity is cleared from the plasma at a rate of 283±101 ml/min, resulting in a dominant half-life (t1/2α) of 14.6±6.7 min and a terminal half-life (t1/2ß) of 1.6 hours±39 min. Only minor amounts of reteplase were immunologically detected in the urine.
Danish: ±101 ml/min, resulterende i en dominerende halveringstid (t1/2α) på 14,6 ± 6,7 minutter og en teminal halveringstid (t1/2β) på 1,6 timer ±39 minutter.
English: For information on product incompatibilities see section 4.2.
Danish: For oplysninger om produkt uforligeligheder se pkt.
English: Tranexamic acid di potassium-hydrogen phosphate phosphoric acid sucrose
Danish: Tranexamsyre Dikaliumhydrogenphosphat Phosphorsyre
English: If the solution is not clear and colourless it should be discarded.
Danish: Hvis opløsningen ikke er klar og farveløs skal den kasseres.
English: Rapilysin is presented as a powder and a solvent for injection (0.56 g powder in a vial and 10 ml solvent in a pre-filled syringe with a reconstitution spike and a needle-pack of 2)
Danish: Rapilysin findes som pulver og solvens til injektionsvæske (0,56 g pulver i et hætteglas og 10 ml solvens i en fyldt injektionssprøjte med rekonstitueringsnåle og en pakning med 2 nåle).
English: Remove the protective flip-cap from the vial of Rapilysin 10 U and clean the rubber closure with an alcohol wipe.
Danish: Beskyttelseshætten fjernes fra hætteglasset med Rapilysin 10 E og gummilukket renses med en alkoholvædet serviet.
English: Haemopericardium, retroperitoneal bleeding, cerebral haemorrhage, epistaxis, haemoptysis, eye haemorrhage and ecchymosis
Danish: Hæmoperikardium, retroperitoneal blødning, cerebral blødning, epistaxis, hæmoptyse, øjenblødning og ekkymose
English: Package leaflet: Information for the user Rapilysin 10 U powder and solvent for solution for injection reteplase
Danish: Indlægsseddel: Information til brugeren Rapilysin 10 E pulver og solvens til injektionsvæske, opløsning reteplase
English: Recurrent ischaemia/angina, hypotension and heart failure/pulmonary oedema
Danish: Tilbagevendende iskæmi/angina, hypotension og hjertesvigt/lungeødem.
English: Rapilysin is administered as a 10 U bolus dose followed by a second 10 U bolus dose 30 minutes later (double bolus).
Danish: Reteplase administreres som en 10 E bolus injektion efterfulgt af en ny 10 E bolus injektion 30 minutter senere (dobbelt bolus).
English: The most common side effect of Rapilysin is bleeding.
Danish: Den oftest forekommende bivirkning ved behandling med Rapilysin er blødning.
English: • if you have acute inflammation of the pancreas or pericardium (the sac surrounding the heart),
Danish: • hvis De har akut inflammation af bugspytkirtlen eller pericardiet (sækken der omgiver hjertet) eller infektion i hjertemusklen (bakteriel endocarditis)
English: 2 pre-filled glass syringes (borosilicate, type I) for single use, with a bromobutyl plunger stopper and a bromobutyl rubber tip cap, containing 10 ml of solvent.
Danish: 2 fyldte glasinjektionssprøjter (borsilicat, type I) til engangsbrug, med brombutyl-stempelprop og brombutyl-hætte.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL OF THE VIAL
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: • Bleeding in the digestive tract (e.g. bloody or black vomit, or stools) in the gums or in the urinary or genital tract
Danish: • Blødning i fordøjelseskanalen (f.eks. blodigt eller sort opkast eller afføring), fra tandkødet eller fra urinvejene
English: Heparin and acetylsalicylic acid are given before and after Rapilysin to reduce the risk of new blood clots forming.
Danish: Heparin og acetylsalicylsyre gives før og efter Rapilysin for at nedsætte risikoen for dannelse af blodpropper.
English: The doctor will ask you questions before giving you Rapilysin, to find out if you have an increased risk of bleeding.
Danish: For at finde ud af om De har forhøjet risiko for blødning, vil lægen stille Dem nogle spørgsmål, før De får Rapilysin.
English: What you need to know before Rapilysin is given to you
Danish: Det skal De vide, før De begynder at tage Rapilysin
English: Reproductive toxicity studies were performed in rats (fertility and embryo-foetotoxicity study including a littering phase) and in rabbits (embryo-foetotoxicity study, dose-range finding only).
Danish: en fase med afkom) og på kaniner (embryo-føtotoksicitet studie, dose-range finding alene).
English: Connect the syringe to the reconstitution spike and transfer the 10 ml of solvent into the vial of Rapilysin 10 U.
Danish: Injektionssprøjten sættes på rekonstitueringsnålen og de 10 ml solvens overføres til hætteglasset med Rapilysin 10 E.
English: The lyophilisate is reconstituted with the contents of the accompanying syringe.
Danish: Den frysetørrede substans opløses med indholdet af den medfølgende solvenssprøjte.
English: Rapilysin 10 U powder and solvent for solution for injection Water for injections for Rapilysin 10 U solution for intravenous use
Danish: Rapilysin 10 E pulver og solvens til injektionsvæske, opløsning Vand til injektionsvæsker til Rapilysin 10 E opløsning til intravenøs anvendelse
English: Death and permanent disability are not uncommonly reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes.
Danish: Død og blivende handicap er ikke usædvanligt hos patienter, som har haft flere slagtilfælde (inkl.
English: Antibody formation to the reteplase molecule has not been seen.
Danish: Der er ikke observeret antistofdannelse overfor reteplasemolekylet.
English: • bleeding in the gastrointestinal, urinary or genital tract within the past 10 days
Danish: • blødning i mave/tarmkanalen eller urinvejene indenfor de sidste 10 dage
English: Insert the spike through the rubber closure into the vial of Rapilysin 10 U.
Danish: Stik nålen igennem gummilukket ind i hætteglasset med Rapilysin 10 E.
English: Remove the tip cap from the syringe.
Danish: Fjern hætten fra spidsen af injektionssprøjten.
English: PUREN Pharma GmbH & Co. KG Tel: +49 (0)89 558909 0
Danish: KG Tel: +49 (0)89 558909 0
English: 2 colourless glass vials (type I) with a rubber (butyl) closure and an aluminium flip-off cap, containing 0.56 mg of powder.
Danish: 2 hætteglas, farveløst glas (type I), med gummilukke (butyl) og en aftagelig hætte (”flip-off hætte”) i aluminium.
English: - high likelihood of left heart thrombus, e.g. mitral stenosis with atrial fibrillation
Danish: - stor sandsynlighed for venstresidig hjerteblodprop, f.eks. mitralstenose med artrieflimren
English: This applies to all medicines including heparin and acetylsalicylic acid, which are given before and after Rapilysin to reduce the risk of new blood clots forming.
Danish: Dette gælder for alle lægemidler, inklusive heparin og acetylsalicylsyre, som gives før og efter Rapilysin for at reducere risikoen for dannelsen af nye blodpropper.
English: Heparin and acetylsalicylic acid should be administered before and following the administration of Rapilysin to reduce the risk of re-thrombosis.
Danish: Heparin og acetylsalicylsyre skal gives før og efter administration af Rapilysin for at nedsætterisikoen for retrombotisering.
English: Marketing Authorisation Holder Actavis Group PTC ehf Reykjavíkurvegi 76-78
Danish: Reykjavikurvegi 76-78
English: The most common complication encountered during reteplase therapy is bleeding.
Danish: Den oftest forekommende komplikation ved reteplasebehandling er blødning.
English: Withdraw 10 ml of Rapilysin 10 U solution back into the syringe.
Danish: Træk 10 ml Rapilysin 10 E opløsning op i injektionssprøjten.
English: • Bleeding at the injection site, e.g. blood blister (haematoma)
Danish: • Blødning på injektionsstedet, f.eks. blåt mærke (hæmatom)
English: given as a bolus injection prior to reteplase therapy followed by an infusion of 1000 I.U.
Danish: Den rekommenderede heparindosis er 5000 IE, givet som en bolus injektion før reteplase behandling, efterfulgt af infusion af 1000 IE pr. time startende efter den anden reteplase bolus injektion.
English: given as a single injection before Rapilysin, followed by an infusion of 1000 I.U.
Danish: Den anbefalede dosis af heparin er 5000 IE, givet som en enkelt injektion før Rapilysin, efterfulgt af en infusion af 1000 IE pr. time, som påbegyndes efter den anden Rapilysin injektion.
English: Except in life-threatening situations, Rapilysin should not be used in pregnant women.
Danish: Rapilysin bør ikke anvendes under graviditet, medmindre situationen er livstruende.
English: Readministration
Danish: Administration
English: Only clear, colourless solutions should be injected.
Danish: Kun klar, farveløs opløsning må injiceres.
English: Other medicines and Rapilysin:
Danish: Brug af anden medicin sammen med Rapilysin
English: coronary artery bypass graft, or surgery or injury to the head or spine), given birth, or had an organ biopsy or other medical / surgical procedure.
Danish: • hvis De indenfor de sidste 3 måneder har haft svære blødninger, større læsioner eller gennemgået større operationer (f.eks. koronar by-pass operation, operation eller skade af hoved eller rygmarv), har født eller fået foretaget en organbiopsi eller en anden medicinsk eller kirurgisk undersøgelse.
English: Rapilysin 10 U powder and solvent for solution for injection.
Danish: Rapilysin 10 E, pulver og solvens til injektionsvæske, opløsning
English: The most frequent adverse drug reaction associated with reteplase treatment is haemorrhage.
Danish: Blødning Den hyppigst forekommende bivirkning ved reteplasebehandling er blødning.
English: Disconnect the syringe from the reconstitution spike.
Danish: Fjern injektionssprøjten fra rekonstitueringsnålen.
English: No other medicines should be injected through the line reserved for Rapilysin, neither at the same time, nor prior to, nor following Rapilysin injection.
Danish: adgang, hverken samtidig eller før eller efter Rapilysin injektionen.
English: What Rapilysin is and what it is used for What you need to know before Rapilysin is given to you How to use Rapilysin
Danish: Det skal De vide, før De begynder at tage Rapilysin Sådan skal De tage Rapilysin Bivirkninger
English: How to use Rapilysin
Danish: Sådan skal De tage Rapilysin
English: Rapilysin should be injected preferably through an intravenous line whose sole purpose is the injection of Rapilysin.
Danish: Rapilysin bør helst injiceres gennem en i.v.
English: 2 reconstitution spikes
Danish: 2 rekonstitueringsnåle.
English: Rapilysin should be injected preferably through an intravenous line that is used only for the injection of Rapilysin.
Danish: adgang, som kun anvendes til injektion af Rapilysin.
English: - systolic blood pressure at entry > 160 mmHg
Danish: - systolisk blodtryk > 160 mm Hg ved behandlingens begyndelse
English: This applies to all products including heparin and acetylsalicylic acid, which should be administered before and following the administration of reteplase to reduce the risk of re-thrombosis.
Danish: Dette gælder for alle lægemidler inklusive heparin og acetylsalicylsyre, som bør indgives før og efter administration af reteplase for at reducere risikoen for nye tromboser.
English: Rapilysin 10 U powder and solvent for solution for injection Reteplase Intravenous use
Danish: Rapilysin10 E pulver og solvens til injektionsvæske, opløsning Reteplase
English: If the same line has to be used, this line (including Y-line) must be flushed thoroughly with a 0.9 % sodium chloride or 5 % glucose solution before and after the Rapilysin injection.
Danish: Hvis den samme slange skal anvendes, skal den (inklusive Y-slangen) skylles omhyggeligt med en opløsning af 0,9 % natriumchlorid eller 5 % glucoseopløsning før og efter injektionen af Rapilysin.
English: Since at present there is no experience with readministration of reteplase, the readministration is not recommended.
Danish: På nuværende tidspunkt foreligger der ingen kliniske data vedrørende gentagen behandling af reteplase.
English: No other medicines should be injected through the line reserved for Rapilysin either at the same time, or prior to, or following Rapilysin injection.
Danish: Ingen andre lægemidler bør injiceres gennem den til Rapilysin reserverede i.v.
English: Breast-feeding
Danish: Specifar ABEE
English: In those patients where the same line has to be used, this line (including Y-line) must be flushed thoroughly with a 0.9 % sodium chloride or 5 % glucose solution prior to and following the Rapilysin injection (see section 4.2 Posology and method of administration).
Danish: adgang, skal denne (inklusive Y-slangen) skylles grundigt med en 0,9 % natriumchlorid opløsning eller 5 % glucose opløsning før og efter Rapilysin injektionen (se pkt.
English: 1 vial + 1 ampoule l t o r
Danish: 1 hætteglas + 1 ampul r l
English: Invented name
Danish: Udtænkt navn
English: Strength Pharmaceutical form Route of administration
Danish: Styrke Lægemiddelform Indgivelsesmåde
English: Fill volume (concentration)
Danish: Indhold (koncentration)
English: 1 vial + 1 sachet
Danish: 1 hætteglas + 1 brev
English: --¹ Each dose of vaccine suspension (3 ml) contains:
Danish: Hver dosis vaccinesuspension (3 ml) indeholder: - i alt 1.25x10
English: Vibrio cholerae O1 Inaba, El Tor biotype (formalin inactivated)
Danish: Vibrio cholerae O1 Inaba, biotype El Tor (formalininaktiveret)
English: Vibrio cholerae O1 Ogawa, classical biotype (heat inactivated)
Danish: Vibrio cholerae O1 Ogawa, klassisk biotype (varmeinaktiveret)
English: - A total of 1.25x10¹¹ bacteria of the following strains: Vibrio cholerae O1 Inaba, classical biotype (heat inactivated)
Danish: bakterier fra følgende stammer: Vibrio cholerae O1 Inaba, klassisk biotype (varmeinaktiveret)
English: Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 31.25x109 bacteria - Recombinant cholera toxin B subunit (rCTB) 1 mg
Danish: - Rekombinant koleratoxin B subenhed (rCTB) 1 mg
English: Prolonged-release tablet Oral use blister (OPA/Alu/DES/PE-Alu) Initiation pack: 21 tablets (7 x 0.26 mg +
Danish: Oral anvendelse Blister (OPA/alu/tørremiddel/PE-alu) Initieringspakning: 21 depottabletter (7 x 0,26 mg + 7 x
English: 1.05 mg
Danish: 0,52 mg + 7 x
English: EMEA Number
Danish: EU nr.
English: The procedure was concluded and on 16 March 2015 the European Commission adopted a Decision
Danish: Efter afslutning af proceduren vedtog Europa-Kommissionen den 16. marts 2015 en beslutning
English: isolates from pigs and chickens with up to 77% classified as resistant.
Danish: fra svin og kyllinger, idet op til 77 % var klassificeret som resistente.
English: Indications for prevention and prophylaxis can no longer be justified.
Danish: Indikationer til forebyggelse kan ikke længere begrundes.
English: Following a request from the European Commission, in July 2013 the CVMP and CHMP adopted scientific advice and detailed considerations on colistin
Danish: På anmodning fra Europa-Kommissionen vedtog CVMP og CHMP i juli 2013 videnskabelige anvisninger og detaljerede overvejelser vedrørende colistin
English: Also, some Salmonella subtypes have reduced sensitivity to colistin.
Danish: Desuden har visse undertyper af Salmonella nedsat følsomhed for colistin.
English: due to a negative benefit-risk assessment.
Danish: på grund af en negativ benefit/risk-vurdering.
English: Barcelona 08017 Spain
Danish: Barcelona 08017
English: 077194 Voluntari Romania
Danish: 077194 Voluntari
English: Colistin has been used since the 1950s both in human and veterinary medicine
Danish: Colistin har været anvendt siden 1950'erne i både human- og veterinærmedicinen
English: Colistin is also used in human medicine.
Danish: Colistin anvendes også i humanmedicinen.
English: The end result is an unnecessary use of colistin.
Danish: Slutresultatet er unødig anvendelse af colistin.
English: Sales of combination products with colistin represented less than 10% of the overall sales of colistin (ESVAC, unpublished data).
Danish: Salget af kombinationsprodukter med colistin udgjorde under 10 % af det samlede salg af colistin (ESVAC, upublicerede data).
English: , polymyxins were the fifth most sold group of antimicrobials (6%), after tetracyclines (37%), penicillins (24%), sulfonamides (10%) and macrolides (7%).
Danish: , var polymyxiner den femte-mest solgte gruppe af antimikrobielle midler (6 %), efter tetracycliner (37 %), penicilliner (24 %), sulfonamider (10 %) og makrolider (7 %).
English: There are also products available for parenteral, intramammary and intrauterine administration, which are not within the scope of this referral.
Danish: Desuden fås produkter, som er til parenteral, intramammær og intrauterin administration og som ikke er omfattet af denne indbringelse.
English: In relation to the total weight of animals ‘at risk' of treatment across 26 EU/EEA countries for which veterinary sales data were available
Danish: Efter den samlede vægt af de dyr, der var "udsat" for behandlingen i 26 EU-/EØS-lande, for hvilke der forelå data om veterinærmedicinsk salg
English: However, it is important to note that stable resistance at the subclinical level (heteroresistance) can remain undetected by conventional culture/sensitivity techniques
Danish: Det er imidlertid vigtigt at bemærke, at stabil resistens på det subkliniske niveau (heteroresistens) kan forblive uopdaget ved sædvanlige teknikker til dyrkning/følsomhedsbestemmelse
English: Romania COOPHAVET SAS Herblon
Danish: Rumænien COOPHAVET SAS Herblon
English: Additionally, it was agreed that the suggested dose of 50,000 IU per kg body weight twice daily was reasonable.
Danish: Derudover blev det vedtaget, at den foreslåede dosis på 50 000 IU pr. kg kropsvægt to gange dagligt var hensigtsmæssig.
English: Specific control programmes for salmonellosis in food-producing animals have been implemented in EU countries.
Danish: EU-landene har indført særlige kontrolprogrammer for salmonellose i fødevareproducerende dyr.
English: Treatment failures could compromise foal health in these cases.
Danish: Behandlingssvigt kan være til fare for føllets helbred i sådanne tilfælde.
English: Since the discovery in China, MCR-1 plasmid-mediated colistin resistance has been reported in a number of countries worldwide.
Danish: Siden opdagelsen i Kina er MCR-1-plasmidmedieret resistens over for colistin beskrevet i en række lande verden over.