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Instructions

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Instruction for use: Tracrium

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Active substance: Atracurium besylate

ATX Code

M03AC04 Atracurium besylate

Pharmacological group

n Cholinolytics (muscle relaxants)

The nosological classification (ICD-10)

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, 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, Urethrotomy, Fistula likvoroprovodyaschih ways, Frontoetmoidogaymorotomiya, Surgical infection, Surgical treatment of chronic limb ulcersm, 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, cholecystectomy, Partial gastric resection, transabdominal 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 and form of release

Solution for intravenous administration 1 ml

Atracurium bezylate 10 mg

Auxiliary substances: benzenesulfonic acid solution; water for injections

In ampoules of 2.5 and 5 ml, in the package 5 pcs.

pharmachologic effect

Pharmacological action - miorelaksiruyuschee.

It blocks n-holinoretseptory skeletal muscles, preventing the depolarization of the end plate of muscle fiber, caused by acetylcholine.

Pharmacokinetics

Inactivated by eliminating Hoffman.

Clinical Pharmacology

The effect develops rapidly - 60-90 s, lasts 15-30 s (depending on the dose) and ends in connection with enzymatic and non-enzymatic hydrolysis of the drug (nonspecific esterases). Removal of neuromuscular block does not depend on hepatic and renal metabolism and excretion. Does not affect n.vagus or ganglia, is not contraindicated in bradycardia associated with the use of anesthetics or with vagal stimulation (during surgery).

Indications

Relaxation of skeletal musculature for endotracheal intubation in general anesthesia, surgical operations, IVL.

Contraindications

Hypersensitivity.

pregnancy and lactation

Perhaps, if the expected effect of therapy exceeds the potential risk to the fetus. Can be used for caesarean section.

Side effects

Convulsions (in patients with predisposing concomitant pathology); Redness of the skin, transient hypotension, bronchospasm (associated with the release of histamine), anaphylactic reactions.

Interaction

Neuromuscular blockade is enhanced by halothane, isoflurane, enflurane, aminoglycosides, polymyxins, spectinomycin, tetracyclines, lincomycin, clindamycin, propranolol, bcc, lidocaine, procainamide, quinidine, furosemide, mannitol, thiazide diuretics, acetazolamide, magnesium sulfate, ketamine, lithium salts, trimetaphane, Hexamethonium; Weaken - anticonvulsants. Masking myasthenia gravis or causing myasthenic syndrome (which leads to increased sensitivity to the drug) procainamide, quinidine, chloroquine, d-penicillamine, trimetiphan, chlorpromazine, steroids, phenytoin, lithium, propranolol, oxprenolol, antibiotics. Incompatible with depolarizing muscle relaxants (suxamethonium), since it is possible to develop a stable neuromuscular block against anticholinesterase agents.

Dosing and Administration

In / in. Adults and children older than 1 month.

Bolus injection

Recommended doses for adults are 0.3-0.6 mg / kg (depending on the required duration of neuromuscular blockade), which provide adequate myoplegia within 15-35 minutes.

Intubation of the trachea can be carried out within 90 seconds after intravenous administration of Tracrium in a dose of 0.5-0.6 mg / kg.

The duration of complete neuromuscular blockade can be increased by the introduction of additional doses at the rate of 0.1-0.2 mg / kg, which is not accompanied by a cumulation of the effect of the drug. Spontaneous recovery of conduction after complete neuromuscular blockade occurs after about 35 min (determined by restoring the tetanic contraction to 95% of the original). Neuromuscular conduction can be quickly restored by the administration of anticholinesterase drugs (neostigmine, etc.) in combination with atropine without the appearance of signs of recurrence.

Infusion introduction

After the initial bolus administration of Tracrium at a dose of 0.3-0.6 mg / kg, it can be administered by continuous infusion at a rate of 0.3-0.6 mg / kg / h to maintain neuromuscular blockade during prolonged surgical operations. This method of administration can be recommended for heart and lung operations.

With artificial hypothermia, accompanied by a decrease in body temperature to 25-26 ° C, the inactivation rate of atracurium decreases, so to maintain complete myoplegia, the infusion rate should be reduced approximately 2-fold.

Elderly patients Tracium is given in standard doses, but it is preferable to use the lower recommended dose range and inject the drug slowly.

If the liver and / or kidney function is impaired, incl. At terminal stage of hepatic or renal insufficiency, Tracium is prescribed in standard doses.

Application for diseases of the cardiovascular system. In patients with severe cardiovascular pathology, the initial dose should be administered for at least 60 seconds.

Application in intensive care units. To maintain myoplegia after initial bolus administration at a dose of 0.3-0.6 mg / kg, the tracherium can be administered by continuous infusion at a rate of 11-13 μg / kg / min (0.65-0.78 mg / kg / h). In different patients, the dose is not the same and may change with time. Some patients may require low doses such as 4.5 μg / kg / min (0.27 mg / kg / h) and high doses such as 29.5 μg / kg / min (1.77 mg / kg / H). Spontaneous recovery of neuromuscular conduction (T4 / T1> 0.75) usually occurs after about 60 min (during clinical trials this period was 32 to 108 min) after Tracium infusion and its rate does not depend on the duration of administration of the drug.

Tracium solution when diluted with compatible infusion solutions to obtain atrakurium besylate concentration of at least 0.5 mg / ml remains stable for a specified period of time under normal lighting and at temperatures up to 30 ° C.

Overdose

Symptoms: myoplegia.

Treatment: IVL, anticholinesterase drugs with atropine.

Precautionary measures

In clinically significant cardiovascular pathology and / or the risk of hypotension (hypovolemia) should be administered slowly (within 60 s). Do not mix in one syringe with thiopental or other alkaline drugs. Use with caution in patients with hypersensitivity to histamine.

Storage conditions

In the dark place at a temperature of 2-8 ° C (do not freeze).

Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiry date printed on the package.

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