natgillin/translations-raw huggingface dataset:
Den primære effektmålsanalyse [firesidet sammensætning af død, MI, akut revaskularisering af arterien (UTVR) og trombolytisk redningsaktion (TBO) efter 48 timer] viste 37% relativ og 3, 9% absolut reduktion i eptifibatid- gruppen (6, 6% hændelser imod 10, 5%, p = 0, 0015).
The primary endpoint analysis [quadruple composite of death, MI, urgent target vessel revascularisation (UTVR) and thrombolytic bail-out (TBO) at 48 hours] showed a 37% relative and 3.9% absolute reduction in the eptifibatide group (6.6% events versus 10.5%, p = 0.0015).
Resultaterne af det primære effektmål var hovedsageligt kendetegnet ved reduktion i forekomsten af enzymatisk MI, identificeret som forekomsten af tidlig forøgelse af kardielle enzymer efter PCI (80 ud af 92 myokardieinfarkter i placebogruppen over for 47 ud af 56 i eptifibitid- gruppen).
47 out of 56 MIs in the eptifibitide group).
Forlænget blødningstid Indgift af eptifibatid ved intravenøs bolus og infusion forårsager op til 5 gange stigning i blødningstiden.
Prolongation of bleeding time Administration of eptifibatide by intravenous bolus and infusion causes up to a 5-fold increase in bleeding time.
Denne stigning er hurtig reversibel efter seponering af infusionen, og blødningstiden vender tilbage til udgangsværdien inden for cirka 6 (2- 8) timer.
This increase is readily reversible upon discontinuation of the infusion with bleeding times returning towards baseline in approximately 6 (2-8) hours.
Eptifibatids farmakokinetik er lineær og dosisproportional for bolusdoser i området fra 90 til 250 mikrogram/ kg og infusionshastigheder fra 0, 5 til 3, 0 mikrogram/ kg/ minut.
The pharmacokinetics of eptifibatide are linear and dose proportional for bolus doses ranging from 90 to 250 microgram/ kg and infusion rates from 0.5 to 3.0 microgram/ kg/ min.
Ved en 2, 0 mikrogram/ kg/ minut infusion opnås gennemsnitlige steady- state eptifibatid- plasmakoncentrationer fra 1, 5 til 2, 2 mikrogram/ ml hos patienter med koronararteriesygdom.
For a 2.0 microgram/ kg/ min infusion, mean steady-state plasma eptifibatide concentrations range from 1.5 to 2.2 microgram/ ml in patients with coronary artery disease.
De nævnte plasmakoncentrationer opnås hurtigt, når infusionen forudgås af en 180 mikrogram/ kg bolusinjektion.
These plasma concentrations are achieved rapidly when the infusion is preceded by a 180 microgram/ kg bolus.
Graden af eptifibatid binding til humant plasmaprotein er omkring 25%.
The extent of eptifibatide binding to human plasma protein is about 25%.
I samme population er plasmaeliminationshalveringstiden cirka 2, 5 timer, plasmaclearance 55 til 80 ml/ kg/ time og - +fordelingsvolumen cirka 185 til 260 ml/ kg.
In the same population, plasma elimination half-life is approximately 2.5 hours, plasma clearance 55 to 80 ml/ kg/ hr and volume of distribution of approximately 185 to 260 ml/ kg.
Hos raske personer udgjorde den renale udskillelse cirka 50% af den totale udskillelse fra kroppen, cirka 50% af den udskilte mængde udskilles uomdannet.
In healthy subjects, renal excretion accounted for approximately 50% of total body clearance; approximately 50% of the amount cleared is excreted unchanged.
Hos patienter med moderat til svær nyreinsufficiens (kreatininclearance < 50 ml/ minut) er clearance reduceret med cirka 50% og steady- state plasmaværdier omtrent fordoblet.
In patients with moderate to severe renal insufficiency (creatinine clearance < 50 ml/ min), the clearance of eptifibatide is reduced by approximately 50% and steady-state plasma levels are approximately doubled.
I en populationsfarmakokinetisk undersøgelse var der imidlertid ingen tegn på farmakokinetisk interaktion mellem eptifibatid og følgende samtidigt indgivne præparater: amlodipin, atenolol, atropin, captopril, cefazolin, diazepam, digoxin, diltiazem, diphenhydramin, enalapril, fentanyl, furosemid, heparin, lidocain, lisinopril, metoprolol, midazolam, morphin, nitrater, nifedipin og warfarin.
13 diazepam, digoxin, diltiazem, diphenhydramine, enalapril, fentanyl, furosemide, heparin, lidocaine, lisinopril, metoprolol, midazolam, morphine, nitrates, nifedipine, and warfarin.
Toksikologiundersøgelser udført med eptifibatid omfatter undersøgelser med gentagne doser hos rotter, kaniner og aber, reproduktionsundersøgelser hos rotter og kaniner, in vitro og in vivo genetiske toksicitetsundersøgelser og irritations -, overfølsomheds - og antigenicitetsundersøgelser.
Toxicology studies conducted with eptifibatide include single and repeated dose studies in the rat, rabbit and monkey, reproduction studies in the rat and rabbit, in vitro and in vivo genetic toxicity studies, and irritation, hypersensitivity and antigenicity studies.
Teratologiske undersøgelser er udført med kontinuerlig intravenøs infusion af eptifibatid til drægtige rotter med totale daglige doser på op til 72 mg/ kg/ dag (omkring 4 gange den anbefalede maksimale humane dosis baseret på legemsoverfladeareal), og til drægtige kaniner med totale daglige doser på op til 36 mg/ kg/ dag (omkring 4 gange den anbefalede maksimale humane dosis baseret på legemsoverfladeareal).
Teratology studies have been performed by continuous intravenous infusion of eptifibatide in pregnant rats at total daily doses of up to 72 mg/ kg/ day (about 4 times the recommended maximum daily human dose on a body surface area basis) and in pregnant rabbits at total daily doses of up to 36 mg/ kg/ day (about 4 times the recommended maximum daily human dose on a body surface area basis).
Disse undersøgelser viste ingen tegn på forringet fertilitet eller fosterskade på
These studies revealed no evidence of impaired fertility or harm to the foetus due to eptifibatide.
Ovennævnte undersøgelser er således ikke velegnede til at vurdere toksiciteten af eptifibatid på reproduktionsfunktionen (se pkt 4. 6).
Consequently these studies are not suitable to evaluate the toxicity of eptifibatide on reproductive function (see section 4.6).
6. 6.
In the absence of compatibility studies, INTEGRILIN must not be mixed with other medicinal products except those mentioned in 6.6.
Et 10 ml Type I glas hætteglas, lukket med en butylgummiprop og forseglet med et krympet aluminumsegl.
One 100 ml Type I glass vial, closed with a butyl rubber stopper and sealed with a crimped aluminium seal.
INTEGRILIN er forligeligt med 0, 9% natriumchlorid injektionsvæske og med Dextrose 5% i Normosol R med eller uden tilstedeværelse af kaliumchlorid.
INTEGRILIN is compatible with 0.9% sodium chloride solution for infusion and with Dextrose 5% in Normosol R, in the presence or absence of potassium chloride.
Anvend ikke præparatet ved tegn på bundfald eller misfarvning.
Do not use if particulate matter or discoloration is present.
Det er ikke nødvendigt at beskytte INTEGRILIN- opløsning mod lys under selve indgivelsen.
Protection of INTEGRILIN solution from light is not necessary during administration.
Ikke anvendt lægemiddel skal bortkastes efter åbning.
Discard any unused material after opening.
Dato for første MT:
Date of first authorisation:
1. juli 1999 Dato for fornyelse:
1 July 1999 Date of latest renewal:
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEA’ s) hjemmeside http: // www. emea. europa. eu /
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
INTEGRILIN 2 mg/ ml injektionsvæske, opløsning
INTEGRILIN 2 mg/ ml, solution for injection
INTEGRILIN indeholder 2 mg/ ml eptifibatid.
INTEGRILIN contains 2 mg/ ml of eptifibatide.
INTEGRILIN infusionsvæske, opløsning skal anvendes i forbindelse med INTEGRILIN injektionsvæske, opløsning.
INTEGRILIN solution for injection must be used in conjunction with INTEGRILIN solution for infusion.
Leverinsufficiens Erfaringer med patienter med leverinsufficiens er meget begrænsede.
16 Hepatic impairment Experience in patients with hepatic impairment is very limited.
16 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.
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
4. 5).
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).
17 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).
17 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 blodpladetallet falder til < 100. 000/ mm3, er yderligere trombocyttællinger påkrævet for at udelukke pseudotrombocytopeni.
18 100,000/ mm3, further platelet counts are required to rule out pseudothrombocytopaenia.
18 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.
19 Blødning Mindre blødning var en meget almindelig komplikation (> 1/ 10) ved indgift af eptifibatid (13, 1% for eptifibatid mod 7, 6% for placebo).
19 Bleeding Minor bleeding was a very common (> 1/ 10) complication of eptifibatide administration (13.1% eptifibatide vs 7.6% placebo).
20 Inden for hver enkelt frekvensgruppe er bivirkningerne angivet efter sværhedsgrad med den alvorligste angivet først.
20 Within each frequency grouping in the tables below, undesirable effects are presented in decreasing order of seriousness.
Større blødning Type eller sted for større blødning:
Major Bleeding
Femoral arterieindstikssted CABG- relateret Genital/ urinal Gastrointestinal Oral/ oropharyngeal Hæmoglobin/ hæmatokrit reduktion Ikke almindelig
Femoral Artery Access CABG-related Genitourinary Gastrointestinal Oral/ Oropharyngeal Haemoglobin/ Haematocrit decrease
Hjertestop Ventrikelflimren Ventrikeltakykardi Hjerteinsufficiens Atrioventrikulært blok Atrieflimren Vaskulære sygdomme Almindelig
Cardiac Arrest Ventricular Fibrillation Ventricular Tachycardia Congestive Heart Failure Atrioventricular Block Atrial Fibrillation Vascular disorder Common
21 Tabel 2 (nedenfor) viser hyppigheden af blødning efter TIMI- kriterierne og efter invasive hjerte - procedurer i PURSUIT- undersøgelsen.
Table 2 (below) depicts the incidence of bleeding by TIMI criteria and by invasive cardiac procedures in the PURSUIT trial.
22 Bivirkninger rapporteret i ESPRIT- undersøgelsen er anført i Tabel 3.
22 Adverse events reported in the ESPRIT trial are listed in Table 3.
Karsygdomme
23 Vascular disorders
23 * Årsagssammenhæng er ikke fastlagt for alle bivirkninger.
*Causality has not been determined for all adverse events.
Eptifibatid, et syntetisk cyklisk heptapeptid indeholdende seks aminosyrer, som omfatter et cysteinamid og en merkaptopropionyl- rest (desaminocysteinyl -), er en trombocytaggregationshæmmer i klassen RGD( arginin- glycin- aspartat) - mimetika.
24 Eptifibatide, a synthetic cyclic heptapeptide containing six amino acids, including one cysteine amide and one mercaptopropionyl (desamino cysteinyl) residue, is an inhibitor of platelet aggregation and belongs to the class of RGD (arginine-glycine-aspartate)-mimetics.
24 Eptifibatid hæmmer trombocytaggregationen på en dosis - og koncentrationsafhængig måde, som demonstreret ved ex vivo trombocytaggregation ved anvendelse af adenosindiphosphat (ADP) og andre agonister for induktion af pladeaggregation.
Eptifibatide inhibits platelet aggregation in a dose- and concentration-dependent manner as demonstrated by ex vivo platelet aggregation using adenosine diphosphate (ADP) and other agonists to induce platelet aggregation.
I alt 1. 250 patienter gennemgik PCI inden for 72 timer efter randomisering, og de modtog da intravenøs ufraktioneret heparin for at vedligeholde en aktiveret koagulationstid (ACT) på 300- 350 sekunder.
25 after randomisation, in which case they received intravenous unfractionated heparin to maintain an activated clotting time (ACT) of 300-350 seconds.
25 Sammenlignet med placebo reducerede eptifibatid indgivet som 180/ 2, 0 signifikant hyppigheden af primære endpoint- hændelser (Tabel 4); dette svarer til 15 undgåede hændelser per 1000 patienter behandlet.
Compared to placebo, eptifibatide administered as 180/ 2.0 significantly reduced the incidence of the primary endpoint events (table 4): this represents around 15 events avoided for 1,000 patients treated:
I armen med eptifibatid i undersøgelsen fik næsten alle patienter acetylsalicylsyre (99, 7%), og 98, 1% fik thienopyridin (clopidogrel hos 95, 4% og ticlopidin hos 2, 7%).
26 In the eptifibatide arm of the trial, virtually all patients received aspirin (99.7%), and 98.1% received a thienopyridine, (clopidogrel in 95.4% and ticlopidine in 2.7%).
26 MI blev påvist ved CK- MB- laboratorieundersøgelseskriterier.
MI was identified per the CK-MB core laboratory criteria.
Bekræftelse fra den blindede sikkerhedskomité var således ikke påkrævet.
For this diagnosis, within 24 hours after the index PCI procedure, there had to be at least two CK-MB values ≥ 3 x the upper limit of normal; thus, validation by the CEC was not required.
MI kunne også rapporteres efter bedømmelse fra den blindede sikkerhedskomité af en investigator - rapport.
MI could also be reported following CEC adjudication of an investigator report.
I en populationsfarmakokinetisk undersøgelse var der imidlertid ingen tegn på farmakokinetisk interaktion mellem eptifibatid og følgende samtidigt indgivne præparater: amlodipin, atenolol, atropin, captopril, cefazolin, diazepam, digoxin, diltiazem, diphenhydramin, enalapril, fentanyl, furosemid, heparin, lidocain, lisinopril, metoprolol, midazolam, morphin, nitrater, nifedipin og warfarin.
27 diazepam, digoxin, diltiazem, diphenhydramine, enalapril, fentanyl, furosemide, heparin, lidocaine, lisinopril, metoprolol, midazolam, morphine, nitrates, nifedipine, and warfarin.
Teratologiske undersøgelser er udført med kontinuerlig intravenøs infusion af eptifibatid til drægtige rotter med totale daglige doser på op til 72 mg/ kg/ dag (omkring 4 gange den anbefalede maksimale 27 humane dosis baseret på legemsoverfladeareal), og til drægtige kaniner med totale daglige doser på op til 36 mg/ kg/ dag (omkring 4 gange den anbefalede maksimale humane dosis baseret på legemsoverfladeareal).
Teratology studies have been performed by continuous intravenous infusion of eptifibatide in pregnant rats at total daily doses of up to 72 mg/ kg/ day (about 4 times the recommended maximum daily human dose on a body surface area basis) and in pregnant rabbits at total daily doses of up to 36 mg/ kg/ day (about 4 times the recommended maximum daily human dose on a body surface area basis).
Opbevares i den originale yderpakning for at beskytte mod lys.
Store in the original carton in order to protect from light..
Et 10 ml Type I glas hætteglas, lukket med en butylgummiprop og forseglet med et krympet aluminumsegl.
One 10 ml Type I glass vial, closed with a butyl rubber stopper and sealed with a crimped aluminium seal.
INTEGRILIN er forligeligt med 0, 9% natriumchlorid injektionsvæske og med Dextrose 5% i Normosol R med eller uden tilstedeværelse af kaliumchlorid.
INTEGRILIN is compatible with 0.9% sodium chloride solution for injection and with Dextrose 5% in Normosol R, in the presence or absence of potassium chloride.
FREMSTILLER( E) AF DET (DE) BIOLOGISK AKTIVE STOF( FER) OG FREMSTILLER( E) ANSVARLIG( E) FOR BATCHFRIGIVELSE
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
FREMSTILLER/ FREMSTILLERE AF DET (DE) BIOLOGISK AKTIVE STOF( FER) OG FREMSTILLER( E) ANSVARLIG( E) FOR BATCHFRIGIVELSE
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Industriepark 30 – 2220 Heist- Op- Den- Berg Belgien
Industriepark 30-2220 Heist-op-den-Berg Belgium
Durham DL12 8DT Storbritannien
Durham DL12 8DT United Kingdom
Indehaver af MT fortsætter med at udarbejde sikkerhedsoplysninger hver 12. måned.
PSURs: the MAH will continue to provide Periodic Safety Update Reports every 12 months.
33 OPLYSNINGER, DER SKAL ANFØRES < PÅ DEN YDRE EMBALLAGE > < OG > < PÅ DEN INDRE EMBALLAGE >
33 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
{ART/ TYPE}
CARTON
INTEGRILIN 0, 75 mg/ ml infusionsvæske, opløsning eptifibatid
INTEGRILIN 0.75 mg/ ml solution for infusion eptifibatide
Citronsyremonohydrat, natriumhydroxid, vand til injektionsvæsker.
Excipients: citric acid monohydrate, sodium hydroxide, water for injections.
Intravenøs anvendelse Læs indlægssedlen før brug.
Read the package leaflet before use.
Bør ikke anvendes i tilfælde af bundfald.
Do not use if particulate matter is present.
Opbevares i køleskab Opbevar hætteglasset i den ydre karton.
Store in a refrigerator.
Bortkast al ikke anvendt lægemiddel efter åbning.
Discard any unused material after opening.
{ART/ TYPE}
LABEL
INTEGRILIN 0, 75 mg/ ml infusionsvæske, opløsning
INTEGRILIN 0.75 mg/ ml solution for infusion Eptifibatide
36 OPLYSNINGER, DER SKAL ANFØRES < PÅ DEN YDRE EMBALLAGE > < OG > < PÅ DEN INDRE EMBALLAGE >
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
INTEGRILIN 2 mg/ ml injektionsvæske, opløsning eptifibatid
INTEGRILIN 2 mg/ ml solution for injection eptifibatide
INTEGRILIN 2 mg/ ml injektionsvæske, opløsning
INTEGRILIN 2 mg/ ml solution for injection Eptifibatide
- Lægen har ordineret INTEGRILIN til dig personligt.
- This medicine has been prescribed for you.
Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har.
their symptoms are the same as yours.
- Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som
- If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please
INTEGRILINs virkning og hvad du skal bruge det til 2.
What INTEGRILIN is and what it is used for 2.
Det skal du vide, før du begynder at bruge INTEGRILIN 3.
Before you take INTEGRILIN 3.
Sådan skal du bruge INTEGRILIN 4.
How to take INTEGRILIN 4.
Sådan opbevarer du INTEGRILIN 6.
How to store INTEGRILIN 6.
INTEGRILINS VIRKNING OG HVAD DU SKAL BRUGE DET TIL
WHAT INTEGRILIN IS AND WHAT IT IS USED FOR
INTEGRILIN er en pladeaggregationshæmmer.
INTEGRILIN is an inhibitor of platelet aggregation.
Dette betyder, at det hjælper med at forebygge dannelse af blodpropper.
This means that it helps to prevent blood clots from forming.
INTEGRILIN bruges til patienter med tegn på svær koronarinsufficiens defineret som spontane og nylige brystsmerter med unormale ændringer i elektrokardiogrammet eller biologiske forandringer.
INTEGRILIN is used in patients with manifestation of severe coronary insufficiency defined as spontaneous and recent chest pain with electrocardiographic abnormalities or biological changes.
Brug ikke INTEGRILIN:
BEFORE YOU TAKE INTEGRILIN
- hvis du er overfølsom (allergisk) over for eptifibatid eller et af de øvrige indholdsstoffer i
Do not take INTEGRILIN: − if you are allergic (hypersensitive) to eptifibatide or any of the other ingredients of INTEGRILIN − if you have recently had bleeding from your stomach, intestines, bladder or other organs, for example if you have seen abnormal blood in your stool or urine (except from menstrual bleeding) in the past 30 days − if you have had a stroke within the past 30 days or any haemorrhagic stroke (also, be sure your doctor knows if you ever had a stroke) − if you have had a brain tumor or a condition that affects the blood vessels around the brain − if you had a major operation or injury during the past 6 weeks − if you have or have had bleeding problems − if you have or have had difficulty with your blood clotting or a low blood platelet count − if you have or have had severe hypertension (high blood pressure) − if you have or have had severe kidney or liver problems − if you have been treated with another medicinal product of the same type as INTEGRILIN.
FORTÆL VENLIGST LÆGEN, HVIS DU LIDER AF EN AF DISSE TILSTANDE.
PLEASE TELL YOUR DOCTOR IF YOU HAVE HAD ANY OF THESE CONDITIONS.
KONTAKT DIN LÆGE ELLER APOTEKET, HVIS DU HAR SPØRGSMÅL.
IF YOU HAVE ANY QUESTIONS, BE CERTAIN TO ASK THE ADVICE OF YOUR DOCTOR OR HOSPITAL PHARMACIST.
- INTEGRILIN anbefales kun til anvendelse hos voksne patienter indlagt på hjerteafdeling.
41 Take special care with INTEGRILIN: − INTEGRILIN is recommended for use only in adult, hospitalized patients in coronary care units. − INTEGRILIN is not intended for use in children or adolescents less than 18 years of age. − Before and during your treatment with INTEGRILIN, samples of your blood will be tested as a safety measure to limit the possibility of unexpected bleeding. − During use of INTEGRILIN, you will be checked carefully for any signs of unusual or unexpected bleeding.
Især:
Taking other medicines To avoid the possibility of interactions with other medicinal products please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription..
- medicin, der forebygger blodpropper, herunder warfarin, dipyridamol, ticlopidin, acetylsalicylsyre
Particularly: − blood thinners (oral anticoagulants) or − medicines that prevent blood clots, including warfarin, dipyridamole, ticlopidine, acetylsalicylic acid (except for the dose you may be given as part of INTEGRILIN treatment).
Graviditet og amning Anvendelse af INTEGRILIN under graviditet anbefales kun, hvis det er meget vigtigt for dig at få det.
Pregnancy and breast-feeding The use of INTEGRILIN during pregnancy is recommended only if it is very important for you to have it.
Din læge vurderer, om behandlingen kan være for farlig for barnet.
Your doctor will consider whether or not this treatment would be too risky for your baby.
Fortæl det til din læge, hvis du er gravid eller planlægger at blive gravid.
Be sure to tell your doctor if you are pregnant or planning to become pregnant.