Sevorane

Active material: Sevoflurane
When ATH: N01AB08
CCF: Drug for inhalation narcosis
ICD-10 codes (testimony): Z51.4
When CSF: 21.01.01
Manufacturer: ABBOTT LABORATORIES Ltd. (Great Britain)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Liquid for inhalation transparent, Colorless, easily movable.

100 ml – plastic bottles (1) – packs cardboard.
100 ml – vials of dark glass (1) – packs cardboard.

Liquid for inhalation transparent, Colorless, easily movable.

250 ml – plastic bottles (1) – packs cardboard.
250 ml – vials of dark glass (1) – packs cardboard.

Pharmacological action

Drug for inhalation narcosis. Inhalation drug for induction narcosis causes rapid loss of consciousness, that recovers quickly after the cessation of anesthesia.

Induction is accompanied by minimal signs of excitement and irritation of the upper respiratory tract and causes excess secretion in the tracheobronchial tree, and stimulation of the central nervous system. Sevoflurane (like other powerful tools for inhalation anesthesia) causes dose-dependent suppression of the respiratory function and the reduction of blood pressure. In humans, the threshold level of sevoflurane, causes the development of arrhythmias by the action of epinephrine (adrenaline), was comparable to that of isoflurane and halothane exceeds the threshold level.

Sevoflurane has minimal effect on intracranial pressure and does not reduce the reaction with₂. It does not have a clinically significant effect on the function of the liver or kidneys and causes growth of kidney or liver failure. It does not affect the concentration of renal function even after prolonged anesthesia (about 9 no).

The minimum alveolar concentration (MAK) – the concentration, where y 50% patients observed motor response in response to a single stimulation (skin incision). MAC sevoflurane in oxygen is 2.05% adult person aged 40 years. MAC sevoflurane, as well as other halogenated agents, decreases with age and by the addition of nitric oxide.

Pharmacokinetics

Solubility

The low solubility of sevoflurane in blood provides a rapid increase in alveolar concentration upon administration of anesthesia and rapid decrease following termination of inhalation. The ratio of the alveolar concentration and concentration in the inspired mixture through a phase of accumulation 30 minutes after inhalation of sevoflurane 0.85. The launch phase of the alveolar concentration ratio through 5 minutes after inhalation of sevoflurane 0.15.

Distribution and metabolism

The rapid removal of light sevoflurane minimizes drug metabolism. A person less than 5% absorption dose sevoflurane metabolized under the influence of izofermenta Cyp2е1 isoenzymes with formation of geksaftorizopropanola, release of inorganic fluoride and carbon dioxide (or one carbon dioxide). The resulting hexafluoroisopropanol quickly conjugated with glucuronic acid and excreted in the urine. Other metabolic routes are not installed sevoflurane. Sevoflurane is the only fluorinated volatile anesthetics, is not metabolized to trifluoroacetic acid.

The concentration of fluoride ions depends on the duration of anesthesia, the concentration of sevoflurane administered, and the composition of the mixture for anesthesia.

Barbiturates not cause defluorination of sevoflurane.

Approximately 7% Adult, which clinical studies have measured the concentration of inorganic fluoride Abbott, they exceeded 50 M; clinically significant changes in kidney function none of these patients have been detected.

Testimony

— introductory and general anaesthesia in adults and children with surgery in hospital and outpatient.

Dosage regimen

Means for premedication should be selected individually anesthesiologist.

General anesthesia during surgical procedures

During general anesthesia, you need to know the concentration of Sevorana, coming from the evaporator. You can use the vaporizer, specially calibrated to sevoflurane.

Introduction to general anaesthesia

Dose picked individually and titrated to achieve the desired effect with regard to the age and condition of the patient. After inhalation Sevorana, you can enter a short-acting barbiturate or another drug for the induction of general anesthesia. For an introduction to the general anaesthesia Sevorane can be used in oxygen or mixtures of oxygen and nitric oxide.

Before surgical interventions at the Adults and children Sevorana inhalation at concentrations up to 8% generally provides an introduction to general anesthesia in less than 2 m.

Supporting general anesthesia

The required level of general anesthesia can be maintained by inhalation of sevoflurane concentration 0.5-3% in combination with nitric oxide or without.

MAK values for adults and children with age appropriate.

*Term infants. MACK did not determine in preterm infants.

With age, the MAC is reduced. The average concentration of sevoflurane, IAC provides patients aged 80 years, is approximately 50% from that of the patient's age 20 years.

Patients usually quickly emerging from general anesthesia Sevoranom. This may require early postoperative analgesia.

Side effect

From the central and peripheral nervous system: ažitaciâ, drowsiness after general anesthesia of, dizziness.

Children, receiving Sevorane for induction narcosis, There were certain instances independently passing distonicheskih movements, whose relationship with the product is not installed. In a few cases there were Sevorana after applying intermittent convulsions.

Although after loss of consciousness Sevorana usually recovers within a few minutes, Nonetheless, state intellectual capacity for 2-3 days after anesthesia has not been studied. Within a few days after applying Sevorana (as well as other means to narcosis) may experience minor mood changes.

The respiratory system: dose-dependent respiratory depression, increased cough, respiratory disorders (Apnea after intubation, laringospazm).

Cardio-vascular system: dose-dependent inhibition of cardiac activity, reduction or increase in blood pressure, bradycardia, tachycardia.

From the digestive system: nausea, vomiting, increased salivation; in some cases – postoperative hepatitis (communication Sevorana not installed), transient disturbances in liver function tests.

Allergic reactions: in some cases – rash, hives, itch, bronchospasm, anaphylactic or anaphylactoid reactions.

From the laboratory parameters: may be a transient increase in glucose and white blood cell count. During and after anesthesia Sevoranom possible transient increase in serum concentration of inorganic fluoride (the maximum value for 2 hours after cessation of Sevorana and return during 48 h to level before surgery). In clinical studies to increase the concentration of fluoride has not been accompanied by impaired kidney.

Other: chills, fever.

In predisposed patients powerful tools for inhalation anesthesia, including Sevorane, may induce a state of hypermetabolism of skeletal muscle, which leads to an increase of the oxygen demand and the development of clinical syndrome, known as malignant hyperthermia. The first sign of this syndrome is hypercapnia, and clinical signs may include muscle rigidity, taxikardiju, tachypnea, cyanosis, arrhythmias and / or instability BP. Some of these nonspecific signs may also appear during light anesthesia, acute hypoxia, hypercapnia and hypovolemia. Later, can develop kidney failure (should be monitored and, where possible to maintain urine output).

The majority of adverse reactions were mild or moderate and transient.

Contraindications

— confirmed or suspected genetic predisposition to the development of malignant hyperthermia;

-hypersensitivity to sevofluranu or other galogenizirovannym drugs.

FROM caution apply if any of the kidneys, in neurosurgical interventions.

Pregnancy and lactation

Category B. Adequate and well-controlled studies of the safety of drugs in pregnancy did not take place. Use Sevorana when pregnancy is possible only in cases of extreme necessity.

In a clinical study demonstrated Sevorana safety for mother and newborn in the application for anesthesia for caesarean section. Sevorana security during labour and childbirth naturally is not installed.

Unknown, Do sevoflurane allocated with breast milk. To use caution during lactation (breast-feeding).

Cautions

Sevorane can only be used by physicians, have experience of general anesthesia. It is necessary to have ready the equipment for airway management, ventilator, oxygen therapy and resuscitation.

Safety of Sevorana in patients with the human kidney is not installed. In this regard, the drug should be used with caution in patients with renal insufficiency.

In neurosurgical interventions, If the patient has a threat of increased intracranial pressure, the sevoflurane should be used with caution in conjunction with measures, aimed at reducing intracranial pressure, such as hyperventilation.

The level of general anesthesia can be easily and quickly changed, Therefore, for the filing of the Sevorana should only be used by specially calibrated evaporators. With the deepening of general anesthesia point increase in hypotension and respiratory function suppression.

In conjunction with increasing the concentration of anaesthetic Sevorana causes a dose-dependent decrease in HELL. Excessive drop in blood pressure may be associated with deep general anesthesia; in such cases, it can be improved by reducing the concentration of supply Sevorana.

As with any funds for general anesthesia in patients with coronary artery disease is necessary to maintain stable hemodynamics, to prevent myocardial ischemia.

Patients, emerging from general anesthesia, before transport to the police should be carefully monitored.

In the treatment of malignant hyperthermia is a cancellation of drugs, caused its development, / in the introduction of dantrolene sodium and supportive symptomatic therapy.

Data on the development of dependencies in the application no Sevorana.

Effects on ability to drive vehicles and management mechanisms

Patients should be informed, that for some time after anesthesia may deteriorate the ability to perform work, requiring a rapid response, such as driving a car or the use of potentially hazardous machinery.

Replacement over-dried sorbents with₂

Exothermic reaction, that occurs when interacting with sorbents and sevoflurane₂, enhanced, If sorbent dries, eg, with the long-term impact of dry gas. When using Sevorana with over dried sorbents with₂ described rare cases of excessive overheating and/or spontaneous ignition devices for anesthesia. When overheated reservoirs with absorbent₂ You may experience unusual delay increase reduction or unexpected concentrations of inhaled Sevorana (compared with the evaporator).

If the anesthesiologist suspects, which sorbent with₂ peresushen, It should be replaced before using Sevorana. When dry sorbent with₂ led color changing not always. Hence, the absence of color change of the indicator must not be considered proof of adequate hydration. Sorbents With₂ You should regularly change regardless of the colour of the indicator.

Overdose

Symptoms: strengthening the oppressive action on the respiratory system and the heart activity.

Treatment: should stop introduction Sevorana, ensure the maintenance of airway patency, start supporting or controlled ventilation with the introduction of oxygen and maintain adequate function of the cardiovascular system.

Drug Interactions

The safety and efficacy of Sevorana confirmed together with the use of various drugs, often used in surgical practice, including funds, affecting the central nervous system, the autonomic nervous system, muscle relaxants, Antimicrobial drugs (incl. aminoglikozidy), hormones and their synthetic analogues, blood and cardiovascular drugs, including epinephrine(adrenaline).

The ability of sevoflurane displace medications from the serum and tissue proteins is not known.

In clinical studies, adverse events were observed in the application of sevoflurane in patients, who took medicines, actively communicate with squirrels and having a small V_d (eg, phenytoin).

Sevorane can be used with barbiturates and benzodiazepines as well as opioid analgesics.

Expected, benzodiazepines and opioid analgesics reduce sevoflurane MAC.

MAC sevoflurane is reduced, while the use of nitric oxide.

Equivalent MACK dropping by approximately 50% in adults and approximately 25% children.

Sevoflurane has an effect on the intensity and duration of neuromuscular blockade, caused by non-depolarizing muscle relaxants. With the introduction of Sevorana as a supplement to narkozu alfentanil/N₂O it enhances the effects of pancuronium, vecuronium and atracurium. By designating these relaxants combined with sevoflurane their dose should be adjusted so as, in the case of use with isoflurane. Influence of sevoflurane on succinylcholine and the effect of the duration of depolarizing neuromuscular blocking agents has not been studied.

Unnecessarily. potentiation of muscle relaxants observed a few minutes after the beginning of sevoflurane inhalation, reduction in the dose of muscle relaxants during induction of anesthesia may delay intubation or inadequate muscle relaxation.

Among the studied preparations nedepoliarizuth interaction with vekuroniem, pancuronium and atracurium. Although specific recommendations for their application no, Nonetheless, when endotracheal intubation should not reduce the dose of non-depolarizing muscle relaxants; while maintaining the dose of non-depolarizing muscle relaxant anesthesia, probably, should be below, than when anaesthesia N₂O/opiodnymi analgetikami. Additional doses of muscle relaxants are administered with the response to nerve stimulation.

Data on pharmaceutical Sevorana incompatibilities with other drugs are not available.

Conditions of supply of pharmacies

The drug is available by prescription for hospitals.

Conditions and terms

List B. The drug should be stored out of reach of children, at a temperature no higher than 25 ° C. Shelf life – 3 year.