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Instruction for use: Angiox
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Dosage form: Lyophilizate for the preparation of a solution for intravenous administration
Active substance: Bivalirudinum
ATX
B01AE06 Bivalirudin
Pharmacological groups
Thrombin inhibitor direct [Anticoagulants]
The nosological classification (ICD-10)
I20.0 Unstable angina: heberden disease; Angina pectoris; The attack of angina pectoris; recurrent angina; Spontaneous angina; Stable angina pectoris; Angina rest; Angina progressing; Angina mixed; Angina spontaneous; stable angina; Chronic stable angina; Angina Syndrome X
I21 Acute myocardial infarction: Myocardial infarction in the acute phase; Acute Myocardial Infarction; Myocardial infarction with pathologic Q wave and without; Myocardial infarction complicated by cardiogenic shock; Infarction left ventricular; Transmural myocardial infarction; Myocardial infarction netransmuralny (subendocardial); Netransmuralny myocardial infarction; Subendocardial myocardial infarction; The acute phase of myocardial infarction; Acute myocardial infarction;Sub-acute phase of myocardial infarction; Subacute phase of myocardial infarction; Thrombosis of the coronary arteries (the arteries); Threatened myocardial infarction; Myocardial infarction without Q wave
I25 Chronic ischemic heart disease: Coronary heart disease on the background of hypercholesterolemia; Coronary heart disease is a chronic; Coronary heart disease; Stable coronary artery disease; Percutaneous transluminal angioplasty; Myocardial ischemia, arteriosclerosis; Recurrent myocardial ischemia
Z100 * CLASS XXII Surgical practice: Abdominal surgery; adenomectomy; Amputation; Coronary angioplasty; Angioplasty of the carotid arteries; Antiseptic skin treatment for wounds; Antiseptic Hand; Appendectomy; atherectomy; Balloon coronary angioplasty; Vaginal hysterectomy; The coronary bypass; Interventions in the vagina and cervix; Interventions on the bladder; Intervention in the mouth; Restoration and reconstructive surgery; Hand hygiene of medical personnel; Gynecologic surgery; Gynecological intervention; Gynecological surgery; Hypovolemic shock during operations; Disinfection of purulent wounds; Disinfection of wounds edges; Diagnostic intervention; Diagnostic procedures; Cervical Diathermocoagulation; Long-surgery; Replacing the fistula catheters; Infection in orthopedic surgery; Artificial heart valve; cystectomy; Short-term outpatient surgery; Short-term operation; Short surgical procedures; Krikotireotomiya; Blood loss during surgery; Bleeding during surgery and in the postoperative period; Kuldotsentez; laser photocoagulation; laser coagulation; retinal laser coagulation; Laparoscopy; Laparoscopy in Gynecology; CSF fistula; Small gynecological operations; Small surgical procedures; Mastectomy and subsequent plastic; mediastinotomy; Microsurgical operations on the ear; Mukogingivalnye operation; suturing; Minor surgery; neurosurgical operation; Immobilization of the eyeball in ophthalmic surgery; testectomy; pancreatectomy; Perikardektomiya; The period of rehabilitation after surgery; The period of convalescence after surgery; Percutaneous transluminal coronary angioplasty; Pleural thoracentesis; Pneumonia postoperative and posttraumatic; Preparation for surgical procedures; Preparation for surgery; Preparation of the surgeon's hands before surgery; Preparation of the colon for surgical procedures; Postoperative aspiration pneumonia in neurosurgical and thoracic surgery; Postoperative nausea; Postoperative bleeding; postoperative granuloma; postoperative shock; The early postoperative period; myocardial revascularization; Radiectomy; gastric Resection; bowel resection; uterine Resection; liver Resection; enterectomy; Resection of part of the stomach; Reocclusion of the operated vessel; Bonding tissues during surgical procedures; Removal of sutures; Condition after eye surgery; Condition after surgery; Condition after surgery in the nasal cavity; Condition after gastrectomy; Status after resection of the small intestine; Condition after tonsillectomy; Condition after removal of the duodenum; Condition after phlebectomy; Vascular surgery; Splenectomy; Sterilization of surgical instruments; Sterilization of surgical instruments; sternotomy; Dental surgery; Dental intervention in periodontal tissues; strumectomy; Tonsillectomy; Thoracic surgery; Thoracic surgery; total gastrectomy; Transdermal intravascular coronary angioplasty; Transurethral resection; Turbinektomiya; Removal of a tooth; cataract surgery; Removal of cysts; tonsillectomy; Removal of fibroids; Removing the mobile primary teeth; Removing polyps; Removing broken tooth; Removal of the uterus body; Removal of sutures; Fistula likvoroprovodyaschih ways; Frontoetmoidogaymorotomiya; Surgical infection; Surgical treatment of chronic limb ulcers; Surgery; The surgery in the anal area; The surgery on the colon; Surgical practice; The surgical procedure; Surgical interventions; Surgery on the gastrointestinal tract; Surgical procedures on the urinary tract; Surgical procedures on the urinary system; Surgical intervention of the genitourinary system; Surgical procedures on the heart; Surgical manipulation; surgery; Surgery on the veins; Surgical intervention; Vascular surgery; Surgical treatment of thrombosis; Surgery; cholecystectomy; Partial gastric resection; hysterectomy; Percutaneous transluminal coronary angioplasty; Percutaneous transluminal angioplasty; Coronary artery bypass; tooth Extirpation; Extirpation of milk teeth; pulpectomy; pulsative cardiopulmonary bypass; tooth Extraction; teeth Extraction; cataract extraction; Electrocoagulation; endourological intervention; episiotomy; Etmoidotomiya; Complications after tooth extraction
Composition
active substance: Bivalirudin trifluoroacetate (in terms of bivalirudin) 250 mg
Auxiliary substances: mannitol - 125 mg; Sodium hydroxide - q.s. To pH 5.0-5.5
Description of dosage form
Lyophilizate: porous mass from white to almost white.
Reconstituted solution: a clear or slightly opalescent colorless or pale yellow solution.
Characteristic
Bivalirudin is a single-chain polypeptide with a molecular weight of 2180.19, consisting of 20 amino acids and having a core structure of hirudin. As a direct inhibitor of thrombin, bivalirudin inhibits all catalyzed and thrombin-induced reactions, including fibrin formation, activation of clotting factors V, VIII and XIII, activation of protein C, and platelet aggregation. Bivalirudin has a high selectivity for thrombin with an inhibition constant (Ki) of 2.3 nM, and does not require the presence of co-factors.
Pharmachologic effect
Mode of action - Anticoagulant.
Pharmacodynamics
The drug Angiox® contains bivalirudin, a selective, reversible and direct thrombin inhibitor that binds to the catalytic site of thrombin, as well as to the anion-binding site of both free and fibrin linked thrombin.
Thrombin plays a central role in the thrombogenesis process, cleaving fibrinogen to form fibrin monomers and activating the clotting factor XIII to form an active coagulation factor XIIIa, which promotes the formation of covalent cross-links between fibrin molecules, which leads to the formation of a stable thrombus.
Thrombin also activates clotting factors V and VIII, promoting the further formation of thrombin, and activates platelets, stimulating their aggregation and release of granules. Bivalirudin inhibits each of these effects of thrombin.
The binding of bivalirudin to thrombin, and consequently, the inhibition of the latter's activity, is reversible, since thrombin slowly cleaves bivalirudin, Arg3-Pro4-bond, which leads to the restoration of the function of the active site of thrombin. Therefore, initially bivalirudin acts as a complete noncompetitive thrombin inhibitor, but over time becomes a competitive inhibitor capable of initially inhibiting the interaction of thrombin molecules with other clot substrates and, if necessary, inhibiting the coagulation process.
Bivalirudin increases activated partial prothrombin time (APTT), thrombin time (TB), and prothrombin time (PV) of normal human plasma in vitro depending on the concentration.
Bivalirudin does not cause platelet aggregation in the serum obtained from a patient with a heparin-induced thrombocytopenia / thrombosis syndrome in the anamnesis.
In healthy volunteers and patients, bivalirudin exhibits anticoagulant activity, depending on dose and concentration, as evidenced by increased activated clotting time (ABC), APTT, PV / INR (international normalized ratio), and thrombin time (TB). In / in the introduction of bivalirudin causes a significant anticoagulant effect in a few minutes.
Bivalirudin has an antithrombotic effect during percutaneous transluminal coronary intervention (CTBC) and stenting.
The pharmacodynamic effects of bivalirudin can be assessed by measuring anticoagulant activity, including ABC. The magnitude of ABC is positively correlated with the dose and concentration of bivalirudin in plasma. ABC remains unchanged when treated in combination with a GPIIb / IIIa glycoprotein inhibitor.
The available data indicate the safety and feasibility of using bivalirudin in patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia with thrombotic syndrome, but information is limited.
Pharmacokinetics
Pharmacokinetic parameters are linear.
Suction. Bioavailability of bivalirudin for IV administration is complete and immediate.
The average of equilibrium concentration of bivalirudin after constant IV infusion at a rate of 2.5 mg / kg / h is 12.4 μg / ml.
Distribution. Bivalirudin is rapidly distributed between plasma and extracellular fluid. Volume of distribution is 0.1 l / kg. Bivalirudin does not bind to blood plasma proteins (except thrombin) or to red blood cells.
Biotransformation. It is assumed that bivalirudin, like a peptide, undergoes catabolism to the amino acids that make up its composition, followed by the utilization of amino acids in the body. Bivalirudin is metabolized by proteases, including thrombin. The main metabolite formed as a result of the cleavage of the Arg-Pro4 bond of the N-terminal sequence by thrombin is not active due to loss of affinity for the catalytic active thrombin site. About 20% of bivalirudin is excreted unchanged in urine.
Excretion. The dependence of the concentration on time with an iv introduction is well described by a two-chamber model. Excretion is a first-order process with terminal T1 / 2 - (25 ± 12) min in patients with normal renal function. The corresponding clearance is (3.4 ± 0.5) ml / min / kg. T1 / 2 is 35-40 minutes.
Liver failure. The pharmacokinetics of bivalirudin in patients with impaired liver function has not been studied, but it is assumed that it does not change, since bivalirudin is not metabolized with the participation of hepatic enzymes, for example, cytochrome P450 isoenzymes.
Renal insufficiency. Systemic clearance of bivalirudin decreases depending on the glomerular filtration rate (GFR). The clearance of bivalirudin in patients with normal renal function and in patients with a slightly impaired renal function is the same. The clearance decreases by approximately 20% in patients with moderate or severe renal failure, and by 80% in patients on dialysis (Table 1).
Table 1
Pharmacokinetic parameters of bivalirudin in patients with normal and impaired renal function
| Renal function (SKF) | Cl, ml/min/kg | T1/2, min |
| Normal Renal function (≥90 ml/min) | 3,4 | 25 |
| Slight nephatony (60–89 ml/min) | 3,4 | 22 |
| Moderate nephatony (30–59 ml/min) | 2,7 | 34 |
| Hard nephatony (10–29 ml/min) | 2,8 | 57 |
| Patients on dialysis (without dialysis) | 1 | 3,5 h |
Body mass. The dose of bivalirudin is selected depending on the body weight in mg / kg.
Dependence of the pharmacokinetics of bivalirudin on sex and race has not been studied.
Indications for Angiox
As an anticoagulant:
- adult patients with percutaneous transluminal coronary intervention (CTTC), incl. When performing the primary PTCA in patients with acute myocardial infarction (AMI) with ST segment elevation on the ECG;
- adults with unstable angina or AMI without an increase in the ST segment, which is indicated by an urgent or early PTCA.
Contraindications
Hypersensitivity to bivalirudin or other components of the drug, as well as to hirudin (to leeches);
Active bleeding or an increased risk of bleeding due to congenital or acquired hemostatic disorders;
Severe uncontrolled hypertension;
Subacute bacterial endocarditis;
Severe renal failure (GFR <30 mL / min), incl. In patients on dialysis;
Children under 18 years of age (lack of data on effectiveness and safety).
With caution: the preparation of Angiox® should be used with caution in the conduct of beta brachytherapy, taking into account cases of thrombosis during gamma-brachytherapy.
Pregnancy and breast-feeding
There were no controlled studies of the drug during pregnancy. The potential risk for a person is not defined.
It is not established whether bivalirudin penetrates into breast milk.
The drug AngioX® should not be used during pregnancy and during breastfeeding, except when the benefit to the mother exceeds the possible risk to the fetus and baby.
Side effects
The summarized data on adverse reactions noted during clinical trials in patients receiving bivalirudin are given below, according to the frequency of occurrence: very often (≥1 / 10); Often (≥1 / 100, <1/10); Infrequently (≥1 / 1000, <1/100) and rarely (≥1 / 10000, <1/1000).
From the blood and lymphatic system: infrequently - thrombocytopenia, anemia, increased INR.
From the immune system: infrequently - hypersensitivity reactions (including anaphylactic reactions and shock).
From the nervous system: infrequently - intracranial hemorrhage; Rarely - a headache.
From the side of the hearing organ and labyrinthine disorders: rarely - bleeding from the ear.
From the heart: infrequently - a thrombosis of the coronary arteries, pericardial bleeding, angina, ventricular tachycardia, bradycardia.
From the side of the vessels: very often - minor bleeding of different locations; Often -significant bleeding of various locations (including fatal cases), thrombosis (including fatal cases), minor bleeding; Infrequently - hematoma, decreased blood pressure, vascular anomalies; Rarely - vascular pseudoaneurysm.
From the digestive tract: infrequent - retroperitoneal bleeding, vomiting of blood, gastrointestinal bleeding, melena, bleeding gums, nausea; Rarely - esophageal hemorrhage, intraperitoneal bleeding, retroperitoneal hematoma.
On the part of the respiratory system and chest organs: infrequently - pulmonary hemorrhage, pharyngeal bleeding, hemoptysis, epistaxis, dyspnea.
From the skin and subcutaneous tissues: often - bruise; Rarely hives, rash.
From the kidneys and urinary tract: infrequently - hematuria.
From the musculoskeletal and connective tissue: infrequently - chest pain, back pain, pain in the groin.
General disorders and disorders at the injection site: very often - bleeding at the site of the vascular puncture, hematoma at the site of the vascular puncture (diameter <5 cm); Infrequently - a hematoma at the puncture site with a diameter> 5 cm, bruise, pain at the injection site; Rarely - reactions at the injection site.
Injuries, intoxications and complications of procedures: often - coronary stent thrombosis (including fatal cases); Infrequently - reperfusion injury (delayed reperfusion blood flow or its absence).
Bleeding. Data on bleeding were assessed separately from other adverse events (Table 2).
Table 2
The frequency of bleeding, depending on their location (bivalirudin in comparison with heparin + inhibitor glycoprotein IIb / IIIa)
| Localization of bleeding | Bivalirudin (n=2994), % | Heparin + glycoprotein inhibitor IIb/IIIa (n=3008), % | Value đ |
| Location of the vascular catheter | 0,8 | 2,5 | 0,001 |
| Other site of a vascular puncture | 0,2 | 0,2 | 1 |
| Extraperitoneal | 0,2 | 0,5 | 0,062 |
| Gastroenteric | 0,1 | 0,6 | 0,003 |
| Ear, nose or throat | 0,1 | 0,3 | 0,085 |
| Genitourinary | <0,1 | 0,2 | 0,125 |
| Intracraneal | <0,1 | 0,1 | 1 |
| Cardiorespiratory | 0,1 | 0,3 | 0,035 |
| Other | 0,4 | 0,5 | 0,556 |
The frequency of significant bleeding during clinical trials of bivalirudin
| Statistic | Type of therapy | ||||||
| Bivalirudin | Bivalirudin + glycoprotein inhibitor IIb/IIIa | NG / enoxaparin * + glycoprotein inhibitor IIb/IIIa | |||||
| Study Number | 1 | 2 | 3 | 2 | 1 | 2 | 3 |
| Number of patients | 2994 | 4612 | 1800 | 4604 | 3008 | 4603 | 1802 |
| Significant bleeding according to protocol and study population criteria, % | 2.4 | 3 | 5,1 | 5,3 | 4,1 | 5,7 | 8,8 |
| Bleeding due to thrombolysis in myocardial ischemia (not associated with CABG), % | 0.4 | 0,9 | 1,8 | 1,.8 | 0,8 | 1,9 | 3,2 |
Both minor and significant bleeding were significantly less frequent in the group receiving bivalirudin relative to the comparison group receiving heparin and a glycoprotein IIb / IIIa inhibitor. Significant bleeding occurred most often at the site of insertion of the catheter (see Table 3). Other, more rare localizations of hemorrhagic complications (frequency ≥1 / 1000 and <1/100) were alternative sites of puncture, retroperitoneal space, gastrointestinal tract, ear, nose and pharynx.
Additional Information
Adverse events were observed more often in women and patients older than 65 years.
Interaction
Pharmaceutical
Studies of drug interaction with platelet aggregation inhibitors, including acetylsalicylic acid, ticlopidine, clopidogrel, abciximab, eptifibatide and tirofiban were carried out. The results indicate a lack of pharmacodynamic interaction with these drugs.
Given the mechanism of action of these drugs, it can be assumed that the use of bivalirudin together with anticoagulants (heparin, warfarin), thrombolytic agents or antiplatelet agents is accompanied by an increased risk of bleeding.
Dosing and Administration
IV. When the CTKV is administered, the preparation of Angioks® is injected intravenously at a dose of 0.75 mg / kg, followed by immediate continuation of the infusion at a rate of 1.75 mg / kg / h until the end of the procedure.
If necessary, the administration of the drug in the same dose can continue for another 4 hours after the end of PTCA, and then in the next 4-12 hours at a dose of 0.25 mg / kg / h. After CTWC, patients should be under constant monitoring to detect symptoms of myocardial ischemia in a timely manner.
For patients with unstable angina or AMI without an increase in the ST-segment, the initial dose of the preparation of Angioks®, which is injected intravenously, is 0.1 mg / kg followed by immediate infusion of the drug at a dose of 0.25 mg / kg / h for a maximum of 72 hours. If the patient is scheduled to undergo PTCA, bivalirudin is additionally injected in a dose of 0.5 mg / kg before the procedure, followed by infusion of the drug at a dose of 1.75 mg / kg / h until the end of the procedure. After the end of PTCA, the administration of the drug may continue for a further 4-12 hours at a dose of 0.25 mg / kg / h.
In patients who undergo aorto-coronary bypass surgery (CABG) on the working heart, infusion of the drug is carried out before the beginning of the surgical procedure. Immediately before the CAB, bivalirudin is given intravenously at a dose of 0.5 mg / kg with a subsequent infusion of the drug at a dose of 1.75 mg / kg / h before the end of the CABG. If the CABG is planned to be performed under conditions of artificial circulation, IV iv administration of bivalirudin should be discontinued 1 h before surgery, after which it is recommended to start treatment with unfractionated heparin (NG).
Indicators of ABC can be used to assess the activity of bivalirudin. The value of ABC after 5 minutes after the jet injection of bivalirudin should be (365 ± 100) s. If this value is 5 minutes after the administration of the drug does not exceed 225 s, it is necessary to re-inject bivalirudin repeatedly at a dose of 0.3 mg / kg. For ABC values greater than 225 s, further monitoring of this indicator is not required when maintaining the dose of the drug within 1.75 mg / kg / h. In order to reduce the risk of obtaining low ABC values, the prepared concentrate and the diluted solution of the drug must be thoroughly mixed before administration and the initial dose is administered rapidly. The arterial catheter can be removed 2 hours after the termination of the infusion of bivalirudin without subsequent control of the ABC.
Peculiarities of application in individual patient groups
Children and adolescents. The safety and efficacy of bivalirudin in patients younger than 18 years of age have not been studied.
Elderly patients. In elderly patients, caution should be exercised because of the possible age-related reduction in renal function.
Use in patients with impaired renal function. In severe renal failure (GFR <30 ml / min), incl. In patients on dialysis, the preparation of AngioX® is contraindicated. If the renal function is impaired, the dose / speed of the infusion should be adjusted. In patients with moderate renal insufficiency (GFR 30-59 ml / min), which are subject to PTCA and regardless of whether they received bivalirudin for acute coronary syndrome (ACS) or not, the infusion rate should be reduced to 1.4 mg / Kg / h. The initial dose of 0.75 mg / kg, which is injected, does not change. In patients with ACS and impaired renal function of mild to moderate severity, the recommended dose of the preparation AngioX® (0.1 mg / kg jet / 0.25 mg / kg / h as infusion) should not be changed. In patients with impaired renal function It is recommended that the coagulation time be monitored, for example, by ABC. The value of ABC should be checked 5 minutes after the initial dose is sprayed. If the ABC value is less than 225 s, it is necessary to re-inject the drug in a dose of 0.3 mg / kg and again check the ABC 5 minutes after the introduction of a second dose.
Use in patients with impaired liver function. Correction of the dose is not required. Pharmacokinetic studies indicate that the metabolism of bivalirudin in the liver is limited, so the safety and efficacy of bivalirudin in patients with hepatic insufficiency have not been specifically studied.
Simultaneous appointment with other anticoagulants. In patients with AMI with an increase in the ST segment, which is planned for CTKV, standard therapy at the prehospital stage should include clopidogrel and in some cases - NG. Patients can enter the preparation of Angiox® 30 minutes after the end of IV infusion of NG or 8 hours after injection of low molecular weight heparin (LMWH). The preparation of Angiox® can be administered simultaneously with the GPIIb / IIIa glycoprotein inhibitor.
Recommendations for the preparation of the solution and for the infusion. In the vial with the preparation of Angiox ® add 5 ml of water for injection and gently shake the bottle until complete dissolution and a clear solution. Using a sterile syringe with a needle, 5 ml of the resulting solution are taken from the vial, which is then diluted with a solution of 5% dextrose (glucose) or 0.9% sodium chloride solution to a total volume of 50 ml to obtain a final bivalirudin concentration of 5 mg / ml. The prepared reconstituted solution and the diluted solution should be clear or slightly opalescent, from colorless to light yellow. If the solution has a different color or if visible inclusions are detected, its use is not allowed. The reconstituted solution should be stored at a temperature of 2 to 8 ° C for a maximum of 24 hours. Store the diluted solution at 25 ° C for a maximum of 24 hours.
Overdose
Symptoms: an excess of the recommended doses of the preparation of Angiox® was recorded, more than 10 times. There was also an excess of the initial dose administered by struino (more than 7.5 mg / kg). In some patients, bleeding occurred during a drug overdose.
Treatment: in cases of overdose, treatment with bivalirudin should be stopped immediately, and the patient should be monitored for the timely detection of bleeding symptoms. The antidote for bivalirudin is not known, but bivalirudin undergoes hemodialysis.
Special instructions
The drug Angiox® is recommended to be administered simultaneously with acetylsalicylic acid and clopidogrel.
The drug Angiox® should be administered only by a physician with experience in the intensive care unit or interventional cardiology.
Do not enter in / m. The preparation of Angiox® should be administered using an IV system. It is not allowed to use the IV system for the administration of bivalirudin for the administration of the following drugs, because they cause cloudiness of the solution, the formation of microparticles or intensive precipitation: alteplase, amiodarone hydrochloride, amphotericin B, chlorpromazine hydrochloride, diazepam, prochlorperazine edisylate, reteplase, streptokinase and vancomycin Hydrochloride.
Table 4 indicates preparations in which the incompatibility with bivalirudine depends on their concentration in solution.
Table 4
Solutions, the compatibility of which with bivalirudin depends on their concentration
| Name of solution | Compatible Concentration mg/ml | Not Compatible Concentration mg/ml |
| Dobutamine hydrochloride | 4 | 12,5 |
| Famotidine | 2 | 10 |
| Haloperidol lactate | 0,2 | 5 |
| Labetalol hydrochloride | 2 | 5 |
| Lorazepam | 0,5 | 2 |
| Promethazine hydrochloride | 2 | 25 |
The efficacy and safety of the exclusively jet dose of the preparation of Angiox® has not been studied and is therefore not recommended even for short-term PTCA procedures.
Bleeding: during treatment, patients should be under close medical supervision for the timely detection of symptoms and signs of bleeding. Although most of the bleeding associated with bivalirudin occurs in patients undergoing PTCA at the artery puncture site, bleeding during therapy can be of any localization. An unexplained decrease in hematocrit, hemoglobin, or blood pressure may be a sign of latent bleeding. When bleeding symptoms appear, bivalirudin should be discontinued. There is no known antidote for bivalirudin, but its effect quickly disappears (T1 / 2 is 35-40 min).
Simultaneous use with antiaggregants or oral anticoagulants. The combined use of bivalirudin with antiplatelet agents may be accompanied by an increased risk of hemorrhagic complications. Therefore, it is necessary to regularly monitor the clinical and biological parameters of hemostasis with the combined use of bivalirudin with platelet aggregation inhibitors or anticoagulants.
In patients taking warfarin, who were administered bivalirudin, control of INR after discontinuing the administration of bivalirudin should be carried out until the moment it returns to its original value.
Hypersensitivity. In clinical trials, reactions of hypersensitivity of the allergic type were rarely observed. Nevertheless, appropriate precautions should be taken. Patients should be informed of early signs of hypersensitivity reactions that include urticaria, generalized rash, a feeling of heaviness in the chest, shortness of breath, lowering blood pressure and anaphylaxis. In the case of shock, standard anti-shock therapy should be performed. The development of anaphylaxis, including anaphylactic shock with a fatal outcome, was recorded in single cases (≤1 / 10000). Immediate appearance of antibodies to bivalirudin is rare and is not associated with the development of a clinical picture of allergic or anaphylactic reactions. Caution should be exercised in patients who have previously been treated with lepiridin and who have developed antibodies to lepirudin.
Acute stent thrombosis. Acute stent thrombosis (<24 h), diagnosed in patients with AMI with ST-segment elevation, which was performed by the primary PTCA, required the implementation of targeted vascular revascularization. After the primary CHTC, patients should remain in the intensive care unit for at least 24 hours to promptly detect symptoms of myocardial ischemia and promptly provide appropriate care.
The remaining unused product must be disposed of immediately. Do not reuse the syringe or needles. Any unused or consumable material must be disposed of in accordance with local requirements.
Effect on the ability to drive and work with machinery. Studies to study the impact on the ability to drive vehicles and use of mechanisms have not been carried out.
Release form
Lyophilizate for the preparation of a solution for intravenous administration, 250 mg. 250 mg of the active ingredient in a neutral glass type I (Hebrew F.) bottle with a capacity of 10 ml, sealed with a rubber stopper, sealed with an aluminum cap with a detachable plastic cap of the "Flip-off" type. For 10 fl. Placed in a cardboard box with the control of the first autopsy.
Manufacturer
The owner of the registration certificate
Medicins Company Co., Ltd., United Kingdom.
115 L Milton Park, Abingdon, OxfordshireOx14 4SA, United Kingdom.
Manufacturer
Ben Vennew Laboratories Inc., 270 Nosfield Road, Bedford, Ohio 44146, USA.
Issued quality control of Hells Pharma GmbH,
Immermanstrasse 9, 33619 Bielefeld, Germany.
The organization authorized to accept claims on the territory of the Russian Federation - LLC "Raypharm":
Conditions of supply of pharmacies
On prescription.
Storage conditions of the drug Angiox
At temperatures not higher than 25 ° C
Keep out of the reach of children.
The shelf life of the drug Angiox
4 years.
Do not use beyond the expiration date printed on the package.
