FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will evaluate the dose of heparin based from the results from tests of your blood.
Danish: Din læge vil bestemme heparin-dosis ud fra blodprøver.
English: The symptoms of allergic/anaphylactic reactions may include: Respiratory system:
Danish: Symptomerne på allergiske/anafylaktiske reaktioner kan være: Luftveje:
English: In case of re-exposure the incidence of allergic/anaphylactic reactions may reach the five percent level.
Danish: Ved reeksponering er incidensen af allergiske/anafylaktiske reaktioner op mod 5 %.
English: Additional heparin should be administered on the basis of heparin levels measured by protamine titration.
Danish: Yderligere heparin bør gives på basis af de heparinniveauer, der måles ved protamin-titreringen.
English: Administration of aprotinin, especially to patients who have received aprotinin (including aprotinin containing fibrin sealants) in the past requires a careful risk/benefit assessment because an allergic reaction may occur (see sections 4.3 and 4.8).
Danish: Indgift af aprotinin, især til patienter, der har fået aprotinin tidligere (herunder fibrin-vævsklæbere indeholdende aprotinin), kræver en nøje vurdering af fordele og risici, da der kan forekomme en allergisk reaktion (se pkt.
English: You will receive a small amount of <Aprotinin-containing medicinal product> (1 ml) before the operation begins, to test if you are allergic to the <Aprotinin-containing medicinal product>.
Danish: Før operationen får du en lille dosis (1 ml) <lægemiddel, der indeholder aprotinin> for at undersøge, om du er allergisk over for <lægemidlet, der indeholder aprotinin>.
English: if a positive aprotinin-specific IgG antibody test is available, showing an increased risk of an allergic reaction to <Aprotinin-containing medicinal product>.
Danish: - hvis der foreligger en positiv test for aprotinin-specifik IgG-antistof, der viser, at du har en øget risiko for en allergisk reaktion over for <lægemiddel, der indholder aprotinin>.
English: Coronary occlusion/ thrombosis Myocardial infarction Pericardial effusion
Danish: Myokardieiskæmi Koronarokklusion / trombose Myokardieinfarkt Perikardie-effusion
English: Available clinical experience suggests that patients with decreased renal function do not require special dose adjustment.
Danish: Nedsat nyrefunktion Klinisk erfaring tyder ikke på, at patienter med nedsat nyrefunktion kræver særlig dosisjustering.
English: - You have or suspect you have received aprotinin or aprotinin containing fibrin sealants in the last 12 months.
Danish: - Du er blevet behandlet med eller tror, at du kan være blevet behandlet med aprotinin eller fibrinklæber, der indeholder aprotinin, inden for de sidste 12 måneder.
English: Rare: may affect up to 1 in 1,000 patients blood clot in blood vessels (arteries) severe allergic reaction (anaphylactic / anaphylactoid reaction)
Danish: Sjælden: Forekommer hos op til 1 ud af 10.000 - blodpropper i arterier - alvorlig allergisk reaktion (anafylaktisk/anafylaktoid reaktion)
English: if no aprotinin specific IgG antibody test is possible prior to treatment and you have received or you suspect that you have received <Aprotinin-containing medicinal product> in the last 12 months.
Danish: - hvis det ikke er muligt at foretage en test for aprotinin-specifik IgG-antistof før behandlingen, og du har fået eller tror, at du har fået, et lægemiddel, der indeholder aprotinin inden for de sidste 12 måneder.
English: In aprotinin treated patients the neutralisation of heparin by protamine after discontinuation of cardiopulmonary bypass should either be based on a fixed ratio to the amount of heparin applied or be controlled by a protamine titration method.
Danish: Hos aprotinin-behandlede patienter bør neutraliseringen af heparin med protamin efter afslutning af den kardiopulmonale bypass enten baseres på et fast forhold i forhold til den anvendte mængde heparin eller kontrolleres ved protamin-titrering.
English: In case no aprotinin specific IgG antibody test is possible prior to treatment, administration of aprotinin to patients with a suspected previous exposure including in fibrin sealant products during the last 12 months is contraindicated.
Danish: Hvis det ikke er muligt at udføre en aprotininspecifik IgG-antistoftest før behandlingen, er administration af aprotinin kontraindiceret til patienter med en formodet forudgående eksponering inden for de sidste 12 måneder, herunder eksponering for fibrinvævsklæbere.
English: Patients with a positive aprotinin-specific IgG antibody test are at an increased risk of anaphylactic reaction when treated with aprotinin.
Danish: Patienter med positiv aprotininspecifik IgG-antistoftest har øget risiko for en anafylaktisk reaktion ved behandling med aprotinin.
English: The incidence of serum creatinine elevations >2.0 mg/dL above baseline was similar (1.1 % vs 0.8 %) in both the full-dose aprotinin and placebo group, with an odds ratio of 1.16 (0.73 - 1.85) (see section 4.4).
Danish: Forekomsten af stigning i serumkreatinin > 2,0 mg/dl over baseline var den samme (1,1 % vs. 0,8 %) i aprotiningruppen på fuld dosis og i placebogruppen med en odds ratio på 1,16 (0,73-1,85) (se pkt.
English: In rabbits, daily intravenous doses of 100,000 KIU/kg produced no evidence of maternal toxicity, embryotoxicity, fetotoxicity, or teratogenicity.
Danish: Hos kaniner gav daglige intravenøse doser på 100.000 KIE/kg ingen tegn på maternel toksicitet, embryotoksicitet, føtotoksicitet eller teratogenicitet.
English: Cardiovascular system: hypotension Skin and appendages: pruritus, rash, urticaria Digestive system:
Danish: Hud og subkutane væv: Kløe, udslæt, urticaria Fordøjelsessystemet:
English: Graft Conservation Blood drawn from the aprotinin central infusion line should not be used for graft preservation.
Danish: Blod, som bliver udtaget gennem det centrale infusionskateter med aprotinin, må ikke anvendes til præservering af transplantatet.
English: Thus, aprotinin should only be used as authorized in isolated CABG surgery, after careful consideration of the potential risks and benefits.
Danish: Derfor bør aprotinin kun anvendes som indiceret, dvs. ved isoleret koronar bypass-operation, og efter omhyggelig vurdering af fordele og risici.
English: Data from a global pool of placebo-controlled studies in patients undergoing coronary artery bypass graft (CABG) surgery showed that the incidence of serum creatinine elevations >0.5 mg/dL above pretreatment levels was statistically higher at 9.0 % (185/2047) in the full-dose aprotinin group compared with 6.6 % (129/1957) in the placebo group, with an odds ratio of 1.41 (1.12 - 1.79).
Danish: Data fra en global pool af placebokontrollerede studier med patienter, der fik foretaget koronararterie bypass-operation (CABG) viste, at forekomsten af stigning i serumkreatinin > 0,5 mg/dl over niveauet før behandling var statistisk højere i aprotiningruppen på fuld dosis [ 9 % (185/2047)] sammenlignet med placebogruppen [6,6 % (129/1957)] med en odds ratio på 1,41 (1,12-1,79).
English: Adverse drug reactions (ADRs) based on all placebo-controlled clinical studies with aprotinin sorted by CIOMS III categories of frequency (aprotinin n=3817 and placebo n=2682; status: April 2005) are listed in the table below:
Danish: Bivirkninger baseret på alle placebo-kontrollerede kliniske studier med aprotinin opdelt efter frekvenskategorier i henhold til CIOMS III (Council for International Organizations of Medical Sciences) (aprotinin n=3.817 og placebo n=2.682; status: April 2005) er vist i tabellen nedenfor:
English: While protocols vary, a minimal celite ACT of 750 seconds or kaolin ACT of 480 seconds, independent of the effects of haemodilution and hypothermia, is recommended in the presence of aprotinin.
Danish: Da protokollerne varierer, anbefales en minimums celit-ACT på 750 sekunder eller en kaolin-ACT på 480 sekunder ved tilstedeværelse af aprotinin, uafhængigt af effekterne af fortynding af blodet og hypotermi.
English: In the pooled analysis of all placebo-controlled clinical studies, the incidence of investigator-reported myocardial infarction (MI) in aprotinin treated patients was 5.8 % compared to 4.8 % in placebo treated patients, with difference of 0.98 % between the groups (aprotinin n=3817 and placebo n=2682; status: April 2005).
Danish: I en poolet analyse af alle placebokontrollerede kliniske studier var forekomsten af myokardieinfarkt (MI) indberettet af investigator 5,8 % hos aprotininbehandlede patienter sammenlignet med 4,8 % hos placebobehandlede patienter, med en forskel på 0,98 % mellem grupperne (aprotinin n=3.817 og placebo n=2.682; status: April 2005).
English: An analysis of all pooled placebocontrolled studies in patients undergoing coronary artery bypass graft (CABG) has found elevations of serum creatinine values >0.5 mg/dL above baseline in patients with aprotinin therapy (see section 5.1).
Danish: I en analyse af alle poolede placebokontrollerede studier med patienter, der fik foretaget koronar bypass-operation, blev der fundet stigning i serumkreatinin > 0,5 mg/dl over baseline hos patienter i aprotininbehandling (se pkt.
English: Other medicines and <Aprotinin-containing medicinal product> Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med <lægemidler, der indeholder aprotinin> Fortæl altid lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: Mortality For the risk of mortality associated with the use of aprotinin see section 4.4.
Danish: den mortalitetsrisiko, der er forbundet med brugen af aprotinin.
English: Medicines used to prevent the symptoms of allergy (H1-antagonist and a H2-antagonist) may be administered 15 minutes prior to the test dose of <Aprotinin-containing medicinal product>.
Danish: Der kan gives lægemidler, der forebygger allergisymptomer (en H1-antagonist og en H2-antagonist) 15 minutter før, du får testdosis af <lægemidlet, der indeholder aprotinin>.
English: If activated clotting time (ACT) is used to maintain adequate anticoagulation, a minimal celite-ACT of 750 seconds or kaolin-ACT of 480 seconds, independent of the effects of haemodilution and hypothermia, is recommended in the presence of aprotinin.
Danish: Hvis ACT anvendes for at opretholde tilstrækkelig antikoagulation, anbefales en celit-ACT på mindst 750 sekunder eller en kaolinACT på mindst 480 sekunder ved tilstedeværelse af aprotinin, uafhængigt af virkningerne af hæmodilution og hypotermi.
English: Uncommon: may affect up to 1 in 100 patients chest pain (myocardial ischaemia, coronary occlusion / thrombosis), heart attack (myocardial infarction) leakage of heart fluid into the surrounding body cavity (pericardial effusion) blood clot (thrombosis) kidney disease (acute renal failure, renal tubular necrosis) passing less urine than is normal
Danish: Ikke almindelig: Forekommer hos op til 1 ud af 100 behandlede - brystsmerter (myokardieiskæmi, blodprop), hjerteanfald (myokardieinfarkt) - udsivning af væske fra hjertet til hulrummet mellem hjertet og hjertesækken (perikardie-effusion) - blodprop (trombose) - nyresygdom (akut nyresvigt, renal tubulær nekrose) - lavere urinproduktion end normalt
English: If you have kidney problems <Aprotinin-containing medicinal product> should only be used if your doctor/surgeon feels it will be of benefit.
Danish: Hvis du har nyreproblemer, må <lægemidler, der indeholder aprotinin> kun anvendes, hvis din læge/kirurg vurderer, at det vil være en fordel.
English: Mortality Information on mortality from randomized clinical trials is provided in section 5.1.
Danish: Mortalitet Oplysninger om mortaliteten i randomiserede kliniske studier findes i pkt.
English: A further 1 - 2 million KIU should be added to the pump prime of the heart-lung machine. To avoid physical incompatibility of aprotinin and heparin when adding to the pump prime solution, each agent must be added during recirculation of the pump prime to assure adequate dilution prior to admixture with the other component.
Danish: For at undgå fysisk inkompatibilitet af aprotinin og heparin ved tilsætning til pumpens primeropløsning skal hvert enkelt lægemiddel tilsættes under recirkulation af pumpens primer-opløsning for at sikre tilstrækkelig fortynding før tilblanding af det andet lægemiddel.
English: Contents of the pack and other information What <Aprotinin-containing medicinal product> contains [To be completed nationally]
Danish: PAKNINGSSTØRRELSER OG YDERLIGERE OPLYSNINGER <Lægemidlet, der indeholder aprotinin> indeholder: [Udfyldes nationalt]
English: Annex III Summary of Product Characteristics and Package Leaflet
Danish: Bilag III Foreslået formulering til produktresumé og indlægsseddel
English: NAME OF THE MEDICINAL PRODUCT <Aprotinin-containing medicinal product> [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN <Lægemiddel, der indholder aprotinin> [Se Annex I - Udfyldes nationalt]
English: <Aprotinin-containing medicinal product> will usually be given to you lying down by slow injection or infusion (through ‘a drip') through a catheter into a larger vein in your body.
Danish: Det gives som langsom indsprøjtning eller infusion (via et drop) gennem et kateter i en af dine større blodårer.
English: In any case standard emergency treatments for anaphylactic and allergic reactions should be readily available (see section 4.4).
Danish: I alle tilfælde skal standardberedskab til behandling af anafylaktiske og allergiske reaktioner være let tilgængeligt (se pkt.
English: You must not be given <Aprotinin-containing medicinal product>
Danish: Du må ikke få <lægemiddel, der indeholder aprotinin>
English: In rat intravenous studies, daily doses of up to 80,000 KIU/kg produced no maternal toxicity, embryotoxicity, or fetotoxicity.
Danish: I studier med intravenøs indgift til rotter gav daglige doser på op til 80.000 KIE/kg ingen maternel toksicitet, embryotoksicitet eller føtotoksicitet.
English: Common: ≥ 1/100 to < 1/10
Danish: Almindelig: ≥1/100 til <1/10
English: The initial bolus infusion is followed by the administration of a continuous infusion of 250,000 - 500,000 KIU per hour until the end of the operation.
Danish: Efter den initale stødinfusion gives 250.000-500.000 KIE pr. time som kontinuerlig infusion, indtil operationen er overstået.
English: <Aprotinin-containing medicinal product> will only be given if your doctor has done blood tests before to check you are suitable (e.g. an appropriate aprotinin-specific IgG antibody test), otherwise other medicines may be a better option for you.
Danish: Du vil kun få <lægemiddel, der indeholder aprotinin>, hvis din læge først har taget blodprøver for at kontrollere, at det er det rigtige til dig (fx en passende test for aprotinin-specifik IgG-antistof).
English: Aprotinin should not be used when CABG surgery is combined with another cardiovascular surgery because the benefit risk balance of aprotinin in other cardiovascular procedures has not been established.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Aprotinin må ikke anvendes, når koronar bypass-operation kombineres med anden kardiovaskulær kirurgi, da fordele og risici ved at anvende aprotinin ved andre kardiovaskulære procedurer ikke er fastslået.
English: Standard emergency treatment for allergic/anaphylactic reactions should be readily available during treatment with aprotinin.
Danish: Standardberedskab til behandling af anafylaktiske og allergiske reaktioner skal være let tilgængeligt under behandling med aprotinin.
English: General disorders or administration site conditions
Danish: Almene symptomer og reaktioner på administrationssted et
English: Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Danish: 4.3 Kontraindikationer Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: For adult patients the following dose regimen is recommended:
Danish: Den sædvanlige dosis til voksne er:
English: If you are pregnant or breast-feeding <Aprotinin-containing medicinal product> should only be used if your doctor/surgeon finds it will be of benefit.
Danish: Hvis du er gravid eller ammer, må du kun få <lægemidler, der indeholder aprotinin>, hvis din læge/kirurg vurderer, at det vil være en fordel for dig.
English: If you get any side effects, talk to your doctor.
Danish: - Tal med lægen, hvis du får bivirkninger.
English: If any of these occur during administration of <Aprotinin-containing medicinal product> your doctor/surgeon will stop treatment with the drug.
Danish: Hvis noget af ovennævnte forekommer, mens du får <lægemiddel, der indeholder aprotinin>, vil din læge/kirurg stoppe behandlingen.
English: Hepatic impairment No data are available on dosage recommendations for patients with hepatic dysfunction.
Danish: Nedsat leverfunktion Der er ingen tilgængelige oplysninger om dosisanbefalinger til patienter med nedsat leverfunktion.
English: • ADRs derived from post-marketing reports are printed in bold italic
Danish: • Bivirkninger set efter markedsføringen er i fed kursiv.
English: 4.5 Interaction with other medicinal products and other forms of interaction Aprotinin has a dose-dependent inhibitory effect on the action of thrombolytic agents, e.g. streptokinase, urokinase, alteplase (r-tPA).
Danish: Aprotinin har en dosisafhængig inhiberende effekt på trombolytiske midler, f.eks. streptokinase, urokinase og alteplase (r-tPA).
English: Rare: ≥ 1/10,000 to < 1/1,000
Danish: Sjælden: ≥1/10.000 til <1/1.000
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Se Annex I - Udfyldes nationalt]
English: An increase in renal failure and mortality compared to age-matched historical controls has been reported for aprotinin-treated patients undergoing cardiopulmonary bypass with deep hypothermic circulatory arrest during operation of the thoracic aorta.
Danish: Under operation af torakal aorta er der set hyppigere nyresvigt og øget mortalitet hos patienter, der blev behandlet med aprotinin under kardiopulmonal bypass med dyb hypotermi+cirkulationsstop i forhold til historiske kontrolpersoner i samme alderskategori.
English: <Aprotinin-containing medicinal product>
Danish: <Lægemiddel, der indholder aprotinin>
English: What you need to know before you are given <Aprotinin-containing medicinal product>
Danish: DET SKAL DU VIDE, FØR DU FÅR <LÆGEMIDDEL, DER INDEHOLDER APROTININ>
English: asthma (bronchospasm)
Danish: Astma (bronkospasme) Det kardiovaskulære system:
English: Very rare: may affect up to 1 in 10,000 patients swelling on or around the location of the injected skin (injection and infusion site reactions, infusion site (thrombo-) phlebitis) blood clot in the lungs (pulmonary embolism) severe blood clotting disorder that results in tissue damage and bleeding (disseminated intravascular coagulation) inability of the blood to clot or coagulate normally (coagulopathy) severe allergic shock (anaphylactic shock), which is potentially life threatening
Danish: (trombo-)flebitis ved infusionsstedet) - blodprop i lungerne (lungemboli) - alvorlig koagulationsforstyrrelse, der kan medføre vævsbeskadigelse og blødning (dissemineret intravaskulær koagulation) - manglende evne hos blodet til at størkne (koagulere) normalt (koagulopati) - alvorligt allergisk shock (anafylaktisk shock), som kan være livstruende
English: Uncommon: ≥ 1/1,000 to < 1/100
Danish: Ikke almindelig: ≥1/1 000 til <1/100
English: A heparin dose response, assessed by protamine titration, should be performed prior to administration of aprotinin to determine the heparin loading dose.
Danish: Før indgift af aprotinin bør dosis-respons for heparin, vurderet ved protamin-titrering, fastlægges for at bestemme støddosis af heparin.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Danish: DATO FOR FØRSTE MARKEDSFØRINGTILLADELSE [Udfyldes nationalt]
English: Tell your doctor if any of these apply to you, to help him or her decide if <Aprotinin-containing medicinal product> is suitable for you:
Danish: Før du får <lægemiddel, der indeholder aprotinin>, skal du fortælle det til lægen, hvis noget af det følgende gælder for dig, så han/hun bedre kan beslutte, om <lægemiddel, der indeholder aprotinin> er det rigtige for dig:
English: After intravenous injection, rapid distribution of aprotinin occurs into the total extracellular space, leading to an initial decrease in plasma aprotinin concentration with a half-life of 0.3 - 0.7 h. At later time points, (i.e. beyond 5 hours post-dose) there is a terminal elimination phase with a half-life of about 5 - 10 hours.
Danish: Dette fører til et initialt fald i plasmakoncentrationen med en halveringstid på 0,3-0,7 timer.
English: There is no specific substance to counteract the effects of <Aprotinin-containing medicinal product>.
Danish: Hvis du får for meget <lægemiddel, der indeholder aprotinin> Der findes ingen specifikke stoffer, der kan ophæve virkningen af <lægemidlet, der indeholder aprotinin>.
English: All CABG Primary CABG Repeat CABG
Danish: Gentagen CABG
English: Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: Indehaver af markedsføringstilladelsen og fremstiller [Se Annex I - Udfyldes nationalt]
English: Tabulated summary of adverse reactions
Danish: Skematisk oversigt over bivirkningerne
English: How to use <Aprotinin-containing medicinal product>
Danish: SÅDAN FÅR DU <LÆGEMIDDEL, DER INDEHOLDER APROTININ>
English: What <Aprotinin-containing medicinal product> is and what it is used for What you need to know before you are given <Aprotinin-containing medicinal product> How to use <Aprotinin-containing medicinal product> Possible side effects
Danish: Det skal du vide, før du får <lægemiddel, der indeholder aprotinin> Sådan får du <lægemiddel, der indeholder aprotinin> Bivirkninger
English: SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Danish: PRODUKTRESUME OG INDLÆGSSEDDEL
English: Injection and infusion site reactions Infusion site (thrombo-) phlebitis
Danish: (Trombo-)flebitis ved infusionsstedet
English: Immediate packaging Pack size
Danish: Pakningsstørr else
English: Insulatard which has been frozen must not be used.
Danish: Insulatard som har været frossen, må ikke anvendes.
English: Insulatard dosing is individual and determined in accordance with the needs of the patient.
Danish: Insulatard dosering er individuel og fastsættes i overensstemmelse med patientens behov.
English: Insulatard will start to lower your blood sugar about 1½ hours after you inject it, and the effect will last for approximately 24 hours.
Danish: Insulatard begynder at nedsætte blodsukkeret ca. 1½ time efter, at du har injiceret det, og virkningen varer i ca. 24 timer.
English: • Drink alcohol, see Insulatard with alcohol in section 2.
Danish: • Drikker alkohol, se Brug af Insulatard sammen med alkohol under punkt 2.
English: This should be kept in mind if treatment with the combination of pioglitazone and Insulatard is considered.
Danish: Dette skal tages i betragtning, hvis kombinationsbehandling med pioglitazon og Insulatard overvejes.
English: Serious allergic reaction to Insulatard or one of its ingredients (called a systemic allergic reaction) is a very rare side effect, but it can potentially be life threatening.
Danish: Alvorlig allergisk reaktion på Insulatard eller et af de øvrige indholdsstoffer (også kaldet systemisk allergisk reaktion) er en meget sjælden bivirkning, men den kan være livstruende.
English: Insulatard can be used in elderly patients.
Danish: Insulatard kan anvendes til ældre patienter.
English: Insulatard is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes).
Danish: Insulatard anvendes til at sænke det høje blodsukkerniveau hos patienter med sukkersyge (diabetes mellitus).
English: However, the Insulatard dose may need to be adjusted.
Danish: Det kan dog være nødvendigt at justere dosis af Insulatard.
English: Insulatard contains less than 1 mmol sodium (23 mg) per dose, i.e. Insulatard is essentially ‘sodiumfree'.
Danish: Insulatard indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. Insulatard er stort set natriumfrit.