natgillin/translations-raw huggingface dataset:
I PURSUIT- undersøgelsen var INTEGRILIN mere effektivt end placebo til at forebygge dødsfald eller yderligere hjertetilfælde i de første 30 dage efter, at det blev indgivet.
In the PURSUIT trial, INTEGRILIN was more effective than placebo in preventing death or further heart attacks during the 30 days after it was given.
I ESPRIT- undersøgelsen blev der observeret lignende gunstige forhold ved 30 dage.
In the ESPRIT trial, a similar benefit at 30 days was seen.
Hvilken risiko er der forbundet med INTEGRILIN?
What is the risk associated with INTEGRILIN?
Den største risiko ved INTEGRILIN er blødning (hos flere end 1 ud af 10 patienter), og dette kan sommetider være alvorligt.
The main risk of INTEGRILIN is bleeding (in more than one in 10 patients), and this may sometimes be severe.
Andre bivirkninger er ualmindelige eller sjældne.
Other side effects are uncommon or rare.
Se indlægssedlen, hvis du ønsker en udtømmende liste over de rapporterede bivirkninger af INTEGRILIN.
For the full list of all side effects reported with INTEGRILIN, see the Package Leaflet.
INTEGRILIN må ikke anvendes til folk, som kan være overfølsomme (allergiske) over for eptifibatid eller et eller flere af de øvrige indholdsstoffer, eller til patienter som har blødningsproblemer eller har en sygdom, der kunne forårsage blødning (såsom slagtilfælde, meget forhøjet blodtryk), eller hos patienter med svære lever - eller nyreproblemer.
INTEGRILIN should not be used in people who may be hypersensitive (allergic) to eptifibatide or any of the other ingredients, in patients who have bleeding problems or have a disease which may cause bleeding (such as stroke, severe high blood pressure), or in patients with severe liver or kidney problems.
Se indlægssedlen, hvis du ønsker en udtømmende liste over begrænsningerne.
For the full list of restrictions, see the Package Leaflet.
Hvorfor blev INTEGRILIN godkendt?
Why has INTEGRILIN been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) har konkluderet, at fordelene ved INTEGRILIN er større end risiciene til forebyggelse af tidlig myokardieinfarkt.
The Committee for Medicinal Products for Human Use (CHMP) decided that INTEGRILIN’ s benefits are greater than its risks to prevent early myocardial infarction.
Udvalget anbefalede udstedelse af markedsføringstilladelse for INTEGRILIN.
They recommended that INTEGRILIN be given marketing authorisation.
Andre oplysninger om INTEGRILIN:
Other information about INTEGRILIN:
Europa- kommissionen udstedte en markedsføringstilladelse for INTEGRILIN med gyldighed i hele Den Europæiske Union den 1. juli 1999.
The European Commission granted a marketing authorisation valid throughout the European Union for INTEGRILIN on 1 July 1999.
Markedsføringstilladelsen blev fornyet den 1. juli 2004.
The marketing authorisation was renewed on 1 July 2004.
Den fuldstændige EPAR for INTEGRILIN kan ses her.
The full EPAR for INTEGRILIN can be found here.
Dette sammendrag blev sidst opdateret i 02- 2007
This summary was last updated in 02-2007.
Særnavn
EU numbers
Lægemiddelform
Invented name Strengths
Pakningsstørrelser
Pharmaceutical Forms
EU/ 1/ 99/ 109/ 001 Integrilin
Route of administration
1 Hæteglas
Package size
EU/ 1/ 99/ 109/ 002 Integrilin
EU/ 1/ 99/ 109/ 001 Integrilin EU/ 1/ 99/ 109/ 002 Integrilin
Injektionsvæske, opløsning
Intravenous use Intravenous use
Intravenøs anvendelse Hæteglas (glas)
Vial (glass) Vial (glass)
10 Hæteglas
1 vial 1 vial
INTEGRILIN 0, 75 mg/ ml infusionsvæske, opløsning
INTEGRILIN 0.75 mg/ ml, solution for infusion
INTEGRILIN indeholder 0, 75 mg/ ml eptifibatid.
INTEGRILIN contains 0.75 mg/ ml of eptifibatide.
Infusionsvæske, opløsning Klar, farveløs opløsning
Solution for infusion Clear, colourless solution
INTEGRILIN er indiceret til forebyggelse af tidligt opstående myokardieinfarkt hos patienter med ustabil angina eller non- Q tak- myokardieinfarkt med det sidste anfald af brystsmerter inden for 24 timer og med ekg- ændringer og/ eller forhøjede hjerteenzymer.
INTEGRILIN is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 24 hours and with ECG changes and/ or elevated cardiac enzymes.
5. 1).
Patients most likely to benefit from INTEGRILIN treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA (Percutaneous Transluminal Coronary Angioplasty) (see section 5.1).
Dette produkt er udelukkende beregnet til hospitalsbrug af speciallæger med erfaring i behandling af akutte koronarsyndromer.
This product is for hospital use only, by specialist physicians experienced in the management of acute coronary syndromes.
INTEGRILIN infusionsvæske, opløsning skal anvendes i forbindelse med INTEGRILIN injektionsvæske, opløsning.
INTEGRILIN solution for infusion must be used in conjunction with INTEGRILIN solution for injection.
Den anbefalede dosering er en intravenøs bolus på 180 mikrogram/ kg indgivet snarest muligt efter diagnosen, efterfulgt af en kontinuerlig infusion på 2, 0 mikrogram/ kg/ minut i op til 72 timer indtil påbegyndelse af koronararterie bypass- kirurgi (CABG) eller indtil udskrivning fra hospitalet (hvad, der forekommer først).
Adults (≥ 18 years of age) presenting with unstable angina or non-Q-wave myocardial infarction The recommended dosage is an intravenous bolus of 180 microgram/ kg administered as soon as possible following diagnosis, followed by a continuous infusion of 2.0 microgram/ kg/ min for up to 72 hours, until initiation of coronary artery bypass graft (CABG) surgery, or until discharge from the hospital (whichever occurs first).
Hvis der foretages perkutan koronar intervention (PCI) under behandling med eptifibatid, skal infusionen fortsættes i 20- 24 timer efter PCI med en samlet maksimal behandlingsvarighed på 96 timer.
If Percutaneous Coronary Intervention (PCI) is performed during eptifibatide therapy, continue the infusion for 20-24 hours post-PCI for an overall maximum duration of therapy of 96 hours.
Akut eller semi- elektiv kirurgi Hvis patienten har behov for akut eller øjeblikkelig hjertekirurgi under behandlingen med eptifibatid, så afslut straks infusionen.
Emergency or semi-elective surgery If the patient requires emergency or urgent cardiac surgery during the course of eptifibatide therapy, terminate the infusion immediately.
Hvis patienten behøver semi- elektiv kirurgi, så stop infusionen med eptifibatid på et passende tidspunkt for at give tid til, at trombocytfunktionen kan vende tilbage til den normale.
If the patient requires semi-elective surgery, stop the eptifibatide infusion at an appropriate time to allow time for platelet function to return towards normal.
Leverinsufficiens Erfaringer med patienter med leverinsufficiens er meget begrænsede.
2 Hepatic impairment Experience in patients with hepatic impairment is very limited.
4. 3, protrombintid).
Administer with caution to patients with hepatic impairment in whom coagulation could be affected (see section 4.3, prothrombin time).
2 Nyreinsufficiens Hos patienter med moderat nedsat nyrefunktion (kreatininclearance ≥ 30 - < 50 ml/ minut) skal der gives en intravenøs bolusinjektion på 180 mikrogram/ kg efterfulgt af 1 mikrogram/ kg/ minut i kontinuerlig infusion i resten af behandlingsperioden.
Renal impairment In patients with moderate renal impairment (creatinine clearance ≥ 30 - < 50 ml/ min), an intravenous bolus of 180 microgram/ kg should be administered followed by a continuous infusion dose of 1.0 microgram/ kg/ min for the duration of therapy.
4. 3).
Experience in patients with more severe renal impairment is limited (see section 4.3).
Pædiatrisk anvendelse Det anbefales ikke til børn og unge under 18 år på grund af utilstrækkelige oplysninger om sikkerhed og effekt.
Paediatric use It is not recommended for use in children and adolescents below 18 years of age, due to a lack of data on safety and efficacy.
INTEGRILIN må ikke anvendes til behandling af patienter med:
INTEGRILIN must not be used to treat patients with: − hypersensitivity to the active substance or to any of the excipients − evidence of gastrointestinal bleeding, gross genitourinary bleeding or other active abnormal bleeding within the previous 30 days of treatment − history of stroke within 30 days or any history of haemorrhagic stroke − known history of intracranial disease (neoplasm, arteriovenous malformation, aneurysm) − major surgery or severe trauma within past 6 weeks − a history of bleeding diathesis − thrombocytopaenia (< 100,000 cells/mm3) − prothrombin time > 1.2 times control, or International Normalized Ratio (INR) ≥ 2.0 − severe hypertension (systolic blood pressure > 200 mm Hg or diastolic blood pressure > 110 mm Hg on antihypertensive therapy) − severe renal impairment (creatinine clearance < 30 ml/min) or dependency on renal dialysis; − clinically significant hepatic impairment − concomitant or planned administration of another parenteral GP IIb/IIIa inhibitor
inden for de sidste 30 dage før behandling
4.4 Special warnings and precautions for use
Blødning INTEGRILIN er et antitrombotisk stof, der virker ved at hæmme trombocytaggregationen og patienten skal derfor observeres omhyggeligt for tegn på blødning under behandling (se pkt.
Bleeding INTEGRILIN is an antithrombotic agent that acts by inhibition of platelet aggregation; therefore the patient must be observed carefully for indications of bleeding during treatment (see section 4.8).
Kvinder, ældre og patienter med lav kropsvægt kan have en øget blødningsrisiko.
Women, the elderly and patients with low body weight may have an increased risk of bleeding.
Alle potentielle blødningssteder, såsom kateterindføringssteder, arterielle, venøse eller kanyle- injektionssteder, operationssteder, gastrointestinale og genitourinare veje, skal observeres omhyggeligt.
All potential bleeding sites, e. g., catheter insertion sites; arterial, venous, or needle puncture sites; cutdown sites; gastrointestinal and genitourinary tracts must be observed carefully.
Da INTEGRILIN hæmmer trombocytaggregationen, skal der udvises forsigtighed, når det anvendes med andre stoffer, der påvirker hæmostasen, inklusive ticlopidine, clopidogrel, trombolytika, orale antikoagulantia, dextranopløsninger (se pkt.
Because INTEGRILIN inhibits platelet aggregation, caution must be employed when it is used with other medicinal products that affect haemostasis, including ticlopidine, clopidogrel, thrombolytics, oral anticoagulants, dextran solutions (see section 6.2), adenosine, sulfinpyrazone, prostacyclin, non-steroidal anti-inflammatory agents, or dypyridamole (see section 4.5).
Der er begrænsede terapeutiske erfaringer med INTEGRILIN til patienter med generel indikation for trombolytisk behandling (f. eks. akut transmural myokardieinfarkt med nye patologiske Q- takker eller forhøjet ST- segmenter eller venstresidigt ledningsblok i ekg).
3 There is limited therapeutic experience with INTEGRILIN in patients for whom thrombolytic therapy is generally indicated (e. g., acute transmural myocardial infarction with new pathological Q-waves or elevated ST-segments or left bundle branch block in the ECG).
INTEGRILIN bør derfor ikke anvendes i sådanne tilfælde.
Consequently the use of INTEGRILIN is not recommended in these circumstances.
3 Afbryd infusion med INTEGRILIN øjeblikkeligt, hvis der opstår situationer, der kræver trombolytisk behandling, eller hvis patienten skal gennemgå en akut CABG- operation eller har behov for en ballonpumpe i aorta.
Stop the INTEGRILIN infusion immediately if circumstances arise that necessitate thrombolytic therapy or if the patient must undergo an emergency CABG surgery or requires an intraortic balloon pump.
Hvis der forekommer alvorlig blødning, der ikke kan kontrolleres med tryk, så stop øjeblikkeligt infusionen med INTEGRILIN og eventuel ufraktioneret heparin, der gives samtidig.
If serious bleeding occurs that is not controllable with pressure, immediately stop the INTEGRILIN infusion and any unfractionated heparin that is given concomitantly.
Arterielle procedurer Under behandling med eptifibatid er der en betydelig stigning i blødningshyppigheden, især i det femorale arterieområde, hvor kateterspidsen indføres.
Arterial procedures During treatment with eptifibatide there is a significant increase in bleeding rates, especially in the femoral artery area, where the catheter sheath is introduced.
Arteriespidsen kan fjernes, når koagulationen er vendt tilbage til det normale, svarende til at aktiveret koagulationstid (ACT) er mindre end 180 sekunder (almindeligvis 2- 6 timer efter seponering af heparin).
Arterial sheaths may be removed when coagulation has returned to normal (e. g., when activated clotting time [ACT] is less than 180 seconds (usually 2-6 hours after discontinuation of heparin).
Trombocytopeni INTEGRILIN hæmmer trombocytaggregationen, men synes ikke at påvirke trombocytternes levedygtighed.
Thrombocytopaenia INTEGRILIN inhibits platelet aggregation, but does not appear to affect the viability of platelets.
Som vist i kliniske undersøgelser var forekomsten af trombocytopeni lav og på samme niveau hos de patienter, der fik behandling med eptifibatid og dem, der fik placebo.
As demonstrated in clinical trials, the incidence of thrombocytopaenia was low, and similar in patients treated with eptifibatide or placebo.
4. 8).
Thrombocytopaenia, including acute profound thrombocytopaenia, has been observed with eptifibatide administration (see section 4.8).
Trombocyttællinger bør overvåges i følgende tilfælde: før behandling, inden for 6 timer efter administration, og efterfølgende mindst én gang daglig under behandling og straks i tilfælde af kliniske symptomer på uventet blødningstendens.
Platelet counts should be monitored prior to treatment, within 6 hours of administration, and at least once daily thereafter while on therapy and immediately at clinical signs of unexpected bleeding tendency.
Hvis patienten får et betydeligt fald i trombocytterne til < 100. 000/ mm3, så afbryd INTEGRILIN og ufraktioneret heparin samt kontrollér patienten på passende måde.
If the patient experiences a confirmed platelet decrease to < 100,000/ mm3, discontinue INTEGRILIN and unfractionated heparin and monitor and treat the patient appropriately.
En beslutning om at foretage blodpladetransfusion bør baseres på individuel klinisk vurdering.
The decision to use platelet transfusions should be based upon clinical judgment on an individual basis.
Der er ingen data med anvendelse af INTEGRILIN til patienter med tidligere trombocytopeni efter andre parenterale GP IIb/ IIIa- hæmmere, og disse patienter kræver således nøje overvågning, som ovenfor beskrevet.
In patients with previous thrombocytopaenia from other parenteral GP IIb/ IIIa inhibitors, there are no data with the use of INTEGRILIN, and thus these patients require close monitoring as noted above.
Heparin- indgift Heparin- indgift anbefales med mindre, der er en kontraindikation for dette (som ved anamnese med trombocytopeni i forbindelse med brug af heparin).
Heparin administration Heparin administration is recommended unless a contraindication (such as a history of thrombocytopaenia associated with use of heparin) is present.
Til en patient, der vejer ≥ 70 kg, anbefales det at give en bolusdosis på 5. 000 enheder efterfulgt af en konstant intravenøs infusion på 1. 000 enheder/ time.
For a patient who weighs ≥ 70 kg, it is recommended that a bolus dose of 5,000 units is given, followed by a constant intravenous infusion of 1,000 units/ hr.
Hvis patienten vejer < 70 kg, anbefales en bolusdosis på 60 enheder/ kg, efterfulgt af en infusion på 12 enheder/ kg/ time.
If the patient weighs < 70 kg, a bolus dose of 60 units/ kg is recommended, followed by an infusion of 12 units/ kg/ hr.
Over 70 sekunder kan der være øget risiko for blødning.
The activated partial thromboplastin time (aPTT) must be monitored in order to maintain a value between 50 and 70 seconds, above 70 seconds there may be an increased risk of bleeding.
Hvis der skal foretages PCI med udførelse som for UA/ NQMI, så hold øje med den aktiverede koagulationstid (ACT) for at bibeholde en værdi mellem 300- 350 sekunder.
If PCI is to be performed in the setting of UA/ NQMI, monitor the activated clotting time (ACT) to maintain a value between 300-350 seconds.
Indgiv kke heparin, før ACT falder til under 300 sekunder.
Stop heparin administration if the ACT exceeds 300 seconds; do not administer until the ACT falls below 300 seconds.
Protrombintid (PT) og aPTT, serumkreatinin, trombocyttal, hæmoglobin og hæmatokritværdier.
Monitoring of laboratory values Before infusion of INTEGRILIN, the following laboratory tests are recommended before treatment to identify pre-existing haemostatic abnormalities: prothrombin time (PT) and aPTT, serum creatinine, platelet count, haemoglobin and haematocrit levels.
Hæmoglobin, hæmatokrit og blodpladetal skal kontrolleres både inden for 6 timer efter behandlingsstart og mindst én gang daglig, derefter under behandling (eller oftere, hvis der er tegn på et mærkbart fald).
If the platelet count falls below
Hvis blodpladetallet falder til < 100. 000/ mm3, er yderligere trombocyttællinger påkrævet for at udelukke pseudotrombocytopeni.
4 100,000/ mm3, further platelet counts are required to rule out pseudothrombocytopaenia.
4. 9).
Patients must be monitored for bleeding and treated if necessary (see section 4.9).
4 Immunogenicitet Immunogenisk respons eller antistoffer mod eptifibatid er set i isolerede tilfælde hos naive patienter eller i sjældne tilfælde hos patienter efter reeksponering af eptifibatid.
Immunogenicity Immunogenic response or antibodies against eptifibatide have been observed in isolated cases in naïve patients or in rare cases of patients re-exposed to eptifibatide.
Der er kun begrænsede erfaringer med gentagen anvendelse af INTEGRILIN.
Only limited experience exists for readministration of INTEGRILIN.
Ved gentagen behandling med INTEGRILIN, er der derfor ingen forventning om formindsket terapeutisk respons.
If treatment with INTEGRILIN is repeated, no diminished therapeutic response is expected.
INTEGRILIN- behandlede patienter, der havde en protrombintid (PT) > 14, 5 sekunder og fik warfarin samtidig, syntes ikke at have øget risiko for blødning.
INTEGRILIN-treated patients who had a prothrombin time (PT) > 14.5 seconds and received warfarin concomitantly did not appear to be at an increased risk of bleeding.
I et akut myokardieinfarkt- studie syntes eptifibatid imidlertid at øge risikoen for blødning ved indgift med streptokinase.
There was no consistent evidence that eptifibatide increased the risk of major or minor bleeding associated with tissue plasminogen activator in either a PCI or an acute myocardial infarction study; however, eptifibatide appeared to increase the risk of bleeding when administered with streptokinase in an acute myocardial infarction study.
I et akut myokardieinfarkt- studie med 181 patienter blev eptifibatid givet (i regimer med bolusinjektion på op til 180 mikrogram/ kg, efterfulgt af infusion på op til 2 mikrogram/ kg/ minut i op til 72 timer) sammen med streptokinase (1, 5 millioner enheder over 60 minutter).
In an acute myocardial infarction study involving 181 patients, eptifibatide (in regimens up to a bolus injection of 180 microgram/ kg, followed by an infusion up to 2 microgram/ kg/ min for up to 72 hours) was administered concomitantly with streptokinase (1.5 million units over 60 minutes).
Ved de højeste undersøgte infusionshastigheder (1, 3 mikrogram/ kg/ minut og 2, 0 mikrogram/ kg/ minut) var eptifibatid forbundet med en øget hyppighed af blødning og transfusioner sammenlignet med den forekomst, der sås, når streptokinase blev givet alene.
At the highest infusion rates (1.3 microgram/ kg/ min and 2.0 microgram/ kg/ min) studied, eptifibatide was associated with an increased incidence of bleeding and transfusions compared to the incidence seen when streptokinase was given alone.
5. 3).
Animal studies are insufficient with respect to effects on pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Det vides ikke, om eptifibatid udskilles i modermælk.
It is not known whether eptifibatide is excreted in human milk.
Det anbefales at afbryde amning under behandlingsperioden.
Interruption of breast-feeding during the treatment period is recommended.
Ikke relevant, da INTEGRILIN er beregnet til patienter indlagt på hospital.
Not relevant, as INTEGRILIN is intended for use in hospitalised patients.
De fleste bivirkninger hos de patienter, der fik behandling med eptifibatid, var generelt relateret til blødninger eller til hjerte - eller hjertekarhændelser, der forekommer hyppigt hos denne patientpopulation.
The majority of undesirable effects experienced by patients treated with eptifibatide were generally related to bleeding, or to cardiovascular events that occur frequently in this patient population.
Ved den anbefalede terapeutiske dosis, som blev anvendt i PURSUIT- undersøgelsen med næsten 11. 000 patienter, var blødning den hyppigste komplikation, der forekom under behandling med eptifibatid.
At the recommended therapeutic dose, as administered in the PURSUIT trial involving nearly 11,000 patients, bleeding was the most common complication encountered during eptifibatide therapy.
Indgift af eptifibatid er forbundet med en stigning i antallet af større og mindre blødninger, ifølge klassifikation efter Trombolysis in Myocardial Infarction (TIMI) study group kriterierne.
Administration of eptifibatide is associated with an increase in major and minor bleeding, as classified by the criteria of the Thrombolysis in Myocardial Infarction (TIMI) study group.
5 Blødning Mindre blødning var en meget almindelig komplikation (> 1/ 10) ved indgift af eptifibatid (13, 1% for eptifibatid mod 7, 6% for placebo).
5 Bleeding Minor bleeding was a very common (> 1/ 10) complication of eptifibatide administration (13.1% eptifibatide vs 7.6% placebo).
Mindre blødninger blev defineret som spontan kraftig hæmaturi, spontan hæmatemesis, observeret blodtab med et fald i hæmoglobin på mere end 3 g/ dl eller mere end 4 g/ dl uden observeret blødningssted.
Minor bleeding was defined as spontaneous gross haematuria, spontaneous haematemesis, observed blood loss with a haemoglobin decrease of more than 3 g/ dl, or more than 4 g/ dl in the absence of an observed bleeding site.
4. 4, heparin indgift).
Bleeding events were more frequent in patients receiving concurrent heparin while undergoing PCI, when ACT exceeded 350 seconds (see section 4.4, heparin use).
Større blødninger var også meget almindelige (> 1/ 10) og blev rapporteret hyppigere hos de patienter der blev behandlet med eptifibatid end hos dem, der fik placebo, henholdsvis 10, 8% mod 9, 3%.
Major bleeding was also very common (> 1/ 10) and reported more frequently in patients treated with eptifibatide than with placebo, i. e., 10.8% vs 9.3%, respectively.
Større blødninger blev defineret som enten en intrakraniel blødning eller et fald i hæmoglobin- koncentrationer på mere end 5 g/ dl (se tabel 1).
Major bleeding was defined as either an intracranial haemorrhage or a decrease in haemoglobin concentrations of more than 5 g/ dl (see table 1).
Forekomsten af svære eller livstruende blødningshændelser med eptifibatid var almindelig (> 1/ 100, < 1/ 10); 1, 9% mod 1, 1% med placebo.
The incidence of severe or life-threatening bleeding events with eptifibatide was common( > 1/ 100, < 1/ 10); 1.9% vs 1.1% with placebo.
Behandling med eptifibatid øgede i moderat grad behovet for blodtransfusioner (11, 8% mod 9, 3% for placebo).
Eptifibatide treatment increased the need for blood transfusions modestly (11.8% vs 9.3%, placebo).
I undergruppen af patienter, der gennemgik PCI, sås større blødninger almindeligvis hos 9, 7% af de eptifibatid- behandlede patienter mod 4, 6% af dem, der fik placebo.
In the subgroup of patients undergoing PCI, major bleeding was observed commonly, in 9.7% of eptifibatide-treated patients vs 4.6% of placebo-treated patients.