Hirakain - instructions for use, dose, side effects, contraindications

Active substanceLevobupivacaineLevobupivacaine

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Hirocain®

solution for injections

EbbVi Ltd. Russia

Dosage form: & nbspinjection

Composition:

In 1 ml of solution contains:

For dosages of 5 mg / ml

Active substance: levobupivacaine hydrochloride 5.633 mg (equivalent to levobupivacaine 5.0 mg).

Excipients: sodium chloride - 9.0 mg; 2.5 M sodium hydroxide solution - up to pH 4.0-6.5; 2.5 M hydrochloric acid solution up to pH 4.0-6.5; water for injection - up to 1.0 ml.

For dosages of 7.5 mg / ml

Active substance: levobupivacaine hydrochloride 8.449 mg (equivalent to levobupivacaine 7.5 mg).

Excipients: sodium chloride 9.0 mg; 2.5 M sodium hydroxide solution to pH 4.0-6.5; 2.5 M hydrochloric acid solution to pH 4.0-6.5; water for injection - up to 1.0 ml.

Description:

A clear, colorless solution.

Pharmacotherapeutic group:Local anesthetic

ATX: & nbsp

N.01.B.B.10 Levobupivacaine

Pharmacodynamics:

Levobumivacaine is a local anesthetic and long-acting analgesic. Levobupivacaine blocks the transmission of impulses in sensory and motor nerve fibers mainly due to influence on the potential-dependent sodium channels of the cell membrane, although it also causes blockade of potassium and calcium channels. Besides, levobupivacaine prevents the transmission and conduct of impulses in other tissues: the most important role in the development of clinical adverse reactions is its effect on the cardiovascular and central nervous system.

The dose of levobupivacaine is expressed in the amount of free base, while the dose of racemic bupivacaine is expressed in the amount of the hydrochloride salt. Thus, the levobupivacaine solution contains 13% more active substance than the bupivacaine solution. In clinical studies, it has been shown that, at the same prescribed concentrations, the clinical efficacy of levobupivacaine and bupivacaine is similar.

In studies of clinical pharmacology using the model of blockade of the ulnar nerve, it was demonstrated that levobupivacaine has the same clinical effect as bupivacaine.

Data on the safety of levobupivacin when administered for more than 24 hours are limited.

Pharmacokinetics:

Distribution

In clinical studies in humans, it has been shown that the distribution of levobupivacaine after intravenous administration is basically the same as that of bupivacaine.The concentration of levobupivacaine in the blood plasma depends on the dose of the drug and on the route of administration, since the absorption of the drug from the site of administration is influenced by tissue vascularization.

Research in vitro showed that the binding of the drug to plasma proteins in humans is> 97% at a concentration of 0.1 μg / ml to 10 μg / ml.

In studies of clinical pharmacology with intravenous administration of 40 mg of levobupivacaine, the average half-life was approximately 80 ± 22 min, C_max - 1.4 ± 0.2 μg / ml and AUC 70 ± 27 μg^.min / ml.

Epidural administration of 75 mg (0.5%) and 112.5 mg (0.75%) of levobupivacaine, and brachial plexus blocking with levobupivacaine at a dose of 1 mg / kg (0.25%) and 2 mg / kg (0 , 5%), the average C_m_Oh and AUC_(0-24) of the drug is approximately proportional to the dose administered. After epidural administration of 112.5 mg (0.75%) of levobupivacaine, the mean C_m_Oh and AUC 0.58 μg / ml and 3.56 μg h / ml, respectively.

The volume of distribution after intravenous administration is 67 liters.

Metabolism

Levobupivacaine is largely metabolized, in urine and feces the unchanged drug is not detected. The main metabolite of levobupivacaine, 3-hydroxylevepupivacaine, is secreted into the urine in the form of conjugates with glucuronic acid and sulfate ester. In studies in vitro it was shown that cytochrome isoenzymes participate in the metabolism of levobupivacaine CYP3A4 and CYP1A2, thus forming desbutyl-levobupivacaine and 3-hydroxylevepupivacaine, respectively. These studies have shown that the metabolism of levobupivacaine and bupivacaine is similar.

Racemization of levobupivacaine in vivo not found.

Excretion

After intravenous administration levobupivacaine is deduced on average within 48 hours by 95%. 71% are excreted through the kidneys, 24% through the intestines.

When administered as an intravenous infusion, the total plasma clearance of levobupivacaine is 39 l / h, and the final half-life is 1.3 h.

ABOUTevent of a group of patients

Impaired liver function

Data on the pharmacokinetics of levobupivacaine in patients with impaired liver function are not available (see section "Special instructions").

Impaired renal function

There are no data on the pharmacokinetics of levobupivacaine in patients with impaired renal function. Levobupivacaine is largely metabolized, unchanged drug in the urine is not detected.

Indications:

For a dosage of 5 mg / ml

Adults

Anesthesia during surgical interventions

- For large surgical interventions, for example, epidural (including anesthesia during cesarean section), intrathecal, blockade of peripheral nerves.

- For small surgical interventions, for example, infiltration anesthesia, peribulbar blockade (in eye surgery).

KyPain Management

- Continuous epidural infusion, single or multiple bolus epidural administration of the drug for relief of pain, especially in the postoperative period or during labor.

Childrenand

- Anesthesia (ilio-inguinal and ilio-hypogastric blockade).

For a dosage of 7.5 mg / ml

Adults

Anesthesia during surgical interventions

- For large surgical interventions, for example, epidural anesthesia, intrathecal, blockade of peripheral nerves.

- For small surgical interventions, for example, infiltration anesthesia, peribulbar blockade (in eye surgery).

Pain relief syndrome

- Continuous epidural infusion, single or multiple bolus epidural administration of the drug to relieve the pain syndrome, especially in postoperative period.

Childrenand

- Anesthesia (ilio-inguinal and ilio-hypogastric blockade).

Contraindications:

- General contraindications to regional anesthesia;

- gand susceptibility to levobupivacaine or excipients of the drug, as well as to local anesthetic agents of the amide group (see section "Side effect");

- atnutrient regional anesthesia (Bira blockade);

- za significant reduction in blood pressure (for example, with cardiogenic or hypovolemic shock);

- Paratservikalnaya blockade in obstetric practice (see the section "Application during pregnancy and during breast-feeding");

- The dosage of 7.5 mg / ml is contraindicated in obstetric practice because of the increased risk of cardiotoxicity when bupivacaine is administered.

Carefully:

- Administration of the drug lasting more than 24 hours;

- lEvobupivacaine should be used with caution in patients receiving antiarrhythmic drugs with the properties of local anesthetics (mexiletine) and antiarrhythmic drugs III class (with the application of the latter can develop additive toxic effects);

- Rregional anesthesia in patients with cardiovascular diseases, in particular with severe heart rhythm disturbances;

- the patients with previous diseases of the central nervous system;

- the patients receiving other local anesthetics or drugs similar in structure to local anesthetics of the amide type;

- the patients with liver disease or with a decrease in hepatic blood flow (for example, with cirrhosis or alcoholic liver disease).

Pregnancy and lactation:

Pregnancy (for dosages of 5 mg / ml and 7.5 mg / ml)

The drug can not be used for paracervical blockade in pregnant women. Given the cases of bradycardia in the fetus with the introduction of bupivacaine, it is impossible to exclude the same action of levobupivacaine.

There are no clinical data on the use of levobupivacaine in the first trimester of pregnancy. In studies on animals teratogenic effect of the drug was not registered). At the same time, at the systemic exposure level of levobupivacaine, which is achieved in clinical practice in humans, the animals were fixed embryotoxic effects. The potential risk to humans is unknown. Thus, in the absence of a clear need for women in the first trimester of pregnancy levobupivacaine should not be entered.

Pregnancy (for a dosage of 5 mg / ml)

Currently, there is extensive experience in the use of bupivacaine in obstetric surgical interventions (during pregnancy and delivery),while the embryotoxic effect of the drug is not recorded.

Pregnancy (for a dosage of 7.5 mg / ml)

The dosage of 7.5 mg / ml is contraindicated in obstetric practice because of the increased risk of cardiotoxicity when bupivacaine is administered.

Breastfeeding period

Information about whether the levobupivacaine in breast milk, no. However, this drug, apparently, is released during lactation to a lesser degree than bupivacaine. Breastfeeding is possible after local anesthesia.

Dosing and Administration:

The introduction of levobupivacaine should be carried out by a specialist who has the appropriate skills of anesthesia, or under his supervision.

To dilute levobupivacaine 0.9% (9 mg / ml) of sodium chloride solution for injection is used in accordance with aseptic rules.

It was shown that with levobupivacaine in a 0.9% (9 mg / ml) solution of sodium chloride compatible clonidine 8.4 μg / ml, morphine 0.05 mg / ml and fentanyl 4 μg / ml.

Before use, a visual assessment of the drug is necessary. The solution can be used only if it is clear and does not contain visible particles.

When diluting levobupivacaine with alkaline solutions, a precipitate may form. The drug can not be diluted with sodium bicarbonate or simultaneously administered with it. Levobupivacaine Do not mix with other drugs, except those listed in the section above.

In Table 1 below, the recommended doses are given for the most commonly used blockades. For anesthesia (for example, with epidural administration of levobupivacaine for the purpose of arresting the pain syndrome), lower doses are indicated. If you need deep or prolonged anesthesia with a complete motor blockade (eg, epidural or peribulbar), you can use higher concentrations of the drug. Before and during the introduction, it is imperative to perform acPan irradiation test to prevent the levobupivacaine from entering the vascular bed. Data on the safety of levobupivacaine therapy for more than 24 hours are limited. To reduce the risk of developing severe neurological complications, careful monitoring of the patient and the duration of administration of the drug should be made.section "Special instructions").

The aspirate sample should be taken before and during the bolus doses slowly and gradually increasing doses at a rate of 7.5-30 mg / min. At the same time, it is necessary to carefully monitor vital signs and constantly maintain verbal contact with the patient.

When symptoms of a toxic effect appear, the drug should be discontinued immediately.

Maximum doses of the drug

The maximum dose of levobupivacaine is calculated depending on the patient's body weight and physical status, and the dose of the drug is determined by its concentration, place and route of administration. Individual differences in the time of onset of action of the drug and in the duration of the blockade are possible. According to clinical studies, with epidural administration of levobupivacaine, a sensory blockade adequate for surgery appears within 10-15 minutes, and regresses after 6-9 hours.

The maximum recommended single dose of the drug is 150 mg. To maintain a prolonged motor and sensory blockade, prolonged interventions may requirerepeated administration of anesthetic. The maximum dose of levobupivacaine, which can be administered within 24 hours, is 400 mg. When treating pain syndrome in the postoperative period, the dose of the drug should not exceed 18.75 mg / h.

Maximum doses of the drug in obstetrical practice

For anesthesia during caesarean section, the drug should not be administered at a concentration greater than 5.0 mg / ml (see "Contraindications"). The maximum recommended dose is 150 mg.

With epidural infusion for the purpose of analgesia of birth, the dose of levobupivacaine should not be more than 12.5 mg / h.

Maximum doses of the drug the children

The maximum recommended dose of the drug for analgesia in children (with ilio-inguinal or ileum-hypogastric blockade) is 1.25 mg / kg on one side. It is necessary to correct the maximum dose depending on the body weight, constitution and fiscal status of the patient.

The efficacy and safety of levobupivacaine outside these indications is not established.

Maximum doses of the drug the patients of special groups

In elderly and debilitated patients, as well as in acute diseases, the dose of levobupivacaine should be reduced in accordance with the data of the physical status.

When administering the drug for pain relief in the postoperative period, it is necessary to take into account the dose of the anesthetic administered during the surgical intervention.

DunnThere is no information on the use of the drug in patients with severe liver damage (see sections "Special instructions" and "Pharmacokinetics").

Tablitz 1. The recommended dose of the drug with the most commonly used blockade

	Concentration (mg / ml)¹	Dose	Degree of motor blockade
Anesthesia during surgical interventions
Epidural bolus² (slow) administration of the drug during surgical interventions
- Adults	5,0-7,5	10-20 ml (50-150 mg)	From moderate to full
Melong-term epidural administration of the drug³ in cesarean section	5,0	15-30 ml (75-150 mg)	From moderate to full
Intrathecal administration	5,0	3 ml (15 mg)	From moderate to full
Blockade of peripheral nerves	2,5-5,0	1-40 ml (2.5-150 mg)	From moderate to full
Ilio-inguinal or vestibule-hypogastric blockade in children <12 years old	2,5	0.5 ml / kg (1.25 mg / kg on one side)	Not applicable
	5,0	0.25 ml / kg (1.25 mg / kg on one side)	Not applicable
Anesthesia in ophthalmological operations (peribulbar blockade)	7,5	5-15 ml (37.5-112.5 mg)	From moderate to full
Local infiltration anesthesia
Adults	2,5	1 -60 ml (2.5-150 mg)	Not applicable
Pain relief syndrome⁴
Anesthesia of labor (epidural bolus injection⁵)	2,5	6-10 ml (15-25 mg)	From minimal to moderate
Anesthesia of labor (epidural infusion)	1,25	4-10 ml / h (5-12.5 mg / h)	From minimal to moderate
Anesthesia after the surgery period	1,25	10-15 ml / h (12.5-18.75 mg / h)	From minimal to moderate
Anesthesia after the surgery period	2,5	5-7.5 ml / hr (12.5-18.75 mg / h)	From minimal to moderate

1 - levobupivacaine in the form of a solution for injection for the preparation of infusions exists in concentrations of 5.0 mg / ml and 7.5 mg / ml.

2 - Enter for 5 minutes.

3 - Enter for 15-20 minutes.

4 - when using the drug in combination with other drugs to stop the pain syndrome, for example, with opioid analgesics, the dose of levobupivacaine should be reduced; It is also preferable to use the lowerMr.(for example, 1.25 mg / ml).

5 - The minimum recommended interval between intermittent injections is 15 minutes.

The solution does not contain preservatives and should be used immediately after opening the ampsmiling. Remains of the solution must be disposed of.

Side effects:

Unwanted reactions to levobupivacaine are consistent with those when using drugs of this class.The most frequent adverse reactions are lowering blood pressure, nausea, anemia, vomiting, dizziness, headache, fever, pain during the injection procedure, back pain and distress syndrome of the fetus (when the drug is used in obstetric practice).

Undesirable reactions recorded in clinical trials and post-registration observations are reflected in accordance with organ and organ damage and frequency of occurrence: very often (≥ 1/10); often (≥ 1/100, <1/10): infrequently (≥ 1/1000, <1/100), unknown (it is not possible to estimate the frequency from the available data).

Organs or organ system	Frequency of occurrence	Unwanted reaction
Violations of the blood and lymphatic system	Often	Anemia
Impaired immune system disorders	Unknown	Allergic reactions (in serious cases anaphylactic shock), hypersensitivity.
Disturbances from the nervous system	Often	Dizziness, headache.
Disturbances from the nervous system	Unknown	Convulsions, loss of consciousness, drowsiness, syncope, paresthesia, paraplegia, paralysis¹.
Infringements from organa view	Unknown	Blurred vision, ptosis², miosis², enophthalmos².
Cardiological disorders	Unknown	Atrioventricular blockade, cardiac arrest, ventricular tachyarrhythmias, tachycardia, bradycardia.
Vascular disorders	Often	Reduced blood pressure.
Vascular disorders	Unknown	Hyperemia².
Disturbances from the respiratory system, chest and mediastinal organs	Unknown	Stop breathing, laryngeal edema, apnea, sneezing.
Disorders from the gastrointestinal tract	Often	Nausea.
	Often	Vomiting.
	Unknown	Hypesaestion of the oral mucosa, impaired control of the sphincter function¹.
Disturbances from the skin and subcutaneous tissues	Unknown	Angioedema, hives, itching, hyperhidrosis, anhidrosis², erythema.
Disturbances from musculoskeletal and connective tissue	Often	Backache.
Disturbances from musculoskeletal and connective tissue	Unknown	Muscle twitching, muscle weakness.
Disorders from the kidneys and urinary tract	Unknown	Dysfunction of the bladder¹.
Pregnancy, post-natal and perinatal conditions	Often	Distress syndrome of the fetus.
Violations from the sexual organs and mammary gland	Unknown	Priapism¹.
General disorders and disorders at the site of administration	Often	Increased body temperature.
Laboratory and instrumental data	Unknown	Decreased cardiac output, changes in the electrocardiogram.
Injuries, intoxications and Oslomanipulation	Often	Pain during the procedure

1 - may be a symptom or sign of horse tail syndrome.

2 - may be a symptom or sign of transient Horner's syndrome.

When using local anesthetics, unwanted reactions developtoabout, however, they can occur with an overdose or with a random intravascular injection and are of serious nature.

OpiefromThere are cases of cross-sensitivity to various anestheticsPamides.

Random andMr.Tracheal administration of the drug may lead to spinal anesthesia at a very high level.

The effect of the drug on the cardiovascular system is associated with a decrease in conduction, excitability and contractility of the myocardium. This is usually preceded by signs of toxic CNS damage, for example, convulsions, at the same timetime, in rare cases, stopThe heart arises without any prodromal neurologic symptoms. The defeat of the nervous system is rare, but good diagnosed complication regionarna, in particular epidural and spinal anesthesia. It can be connected with directm damage to the spinal cord or spinal nerves, syndrome of the anterior spinal artery, the introduction of an irritant or an unsterile solution. In rare cases, changes are kept constantly.

There is evidence of continued weakness or sensory disturbances associated with the administration of levobupivacaine. Sometimes these phenomena can be permanent. It is difficult to determine whether such long-term effects arise due to the toxic effect of the drug or are signs of undiagnosed traumatic injury during surgery or when other mechanical factors, in particular, the placement of the catheter and manipulations with it, are affected.

There have been reports of the development of horse tail syndrome or the appearance of symptoms and with such possible damage to the base of the spinal cord or roots of the spinal nerves (including weakness of the lower extremities, paresthesia or paralysis,loss of control over bowel movement and / or urination and priapism) associated with levobupivacaine therapy. With the introduction of levobupivacaine for more than 24 hours, these phenomena were more severe and in some cases did not completely disappear (see section "Special instructions").

However, it is impossible to determine whether these phenomena were associated with the action of levobupivacaine, a mechanical trauma of the spinal cord or roots of the spinal nerves, or the collection of blood in area of the base of the spine.

Also, rare cases of transient Horner's syndrome (ptosis, miosis, enofthalm, unilateral sweating and / or hyperemia) associated with the use of local anesthetics, including levobupivacaine. After discontinuing therapy, these phenomena disappear.

Overdose:

After a random intravascular injection of a local anesthetic, an immediate toxic reaction may occur. When an overdose of the drug, its concentration in the plasma sometimes reaches peak values only 2 hours after the injection (depending on the injection site), so the symptoms of toxic damage can be delayed.It is possible to prolong the effect of the drug.

Systemic adverse reactions after an overdose or unintentional intravascular injection of a local long-acting anesthetic include symptoms of cardiovascular and central nervous system damage.

Impact on the CNC

When The development of seizures should be immediately injected intravenously with thiopental sodium or diazepam, titrating the dose appropriately. Thiopental sodium and diazepam can also have a depressing effect on the central nervous system, respiratory and cardiovascular activity. Thus, with the introduction of these drugs, apnea can develop. Drugs that block neuromuscular transmission should be used only if there is the possibility of maintaining airway patency and treating the patient with complete muscle relaxation.

In the absence of timely treatment, seizures, subsequent hypoxia and hypercapnia, as well as depression of cardiac activity under the influence of local anesthetics can cause heart rhythm disturbances, ventricular fibrillation and cardiac arrest.

Effects on the cardiovascular system

Preliminary fluid administration and / or use of vasopressors can prevent or reduce the reduction in blood pressure. With a decrease in blood pressure, intravenous infusion of crystalloids and colloids and / or vasopressor administration in increasing doses (for example, ephedrine 5-10 mg). It also follows how falsely to eliminate all other causes of lowering blood pressure.

With the development of severe bradycardia, it is advisable to administer atropine at a dose of 0.3-1 mg, which allows you to increase heart rate (heart rate) to allowable values. If heart rhythm disturbances occur, appropriate treatment should be performed, ventricular fibrillation requires emergency cardioversion.

Interaction:

In studies in vitro It is shown that cytochrome P450 isoenzymes participate in the metabolism of levobupivacaine CYP3A4 and CYP1A2. The conversion of levobupivacaine may be affected by inhibitors of the isoenzyme CYP3A4 (in particular ketoconazole) and isoenzyme CYP 1A2 (eg, methylxanthines), although there have been no clinical studies of such interactions.

Levobupivacaine should be used with caution in patients receiving antiarrhythmic drugs with the properties of local anesthetics (mexiletine) and antiarrhythmic drugs III class (with the application of the latter can develop additive toxic effects).

Clinical studies on the evaluation of the action of levobupivacaine with its combination with epinephrine were not conducted.

Special instructions:

All types of local or regional anesthesia should be performed in a well-equipped health facility, staff should have experience of regional anesthesia, and be able to diagnose possible unwanted reactions and conduct appropriate treatment.

Levobupivacaine can cause allergic reactions, cardiovascular disorders and neurological disorders.

In patients with cardiovascular diseases, in particular with severe heart rhythm disorders, regional anesthesia with levobupivacaine should be carried out with caution (see the section "With caution").

In patients with previous diseases of the central nervous system, the ingestion of a local anesthetic in the central nervous system during epidural administration may exacerbate these diseases.Therefore, when planning epidural anesthesia in these patients it is necessary to conduct an appropriate clinical evaluation.

Epidural anesthesia

Concentrated solution of levobupivacaine (0.5-0.75%) with epidural anesthesia should be administered fractional by 3-5 ml, gradually increasing the dose, with the interval between administrations should be sufficient to have time to determine the toxic manifestations in the event of drug exposure in the lumen of the vessel or intrathecally. Cases of severe bradycardia, lowering of arterial pressure and respiratory failure with cardiac arrest during application of local anesthetics are described (some of these cases ended in a fatal outcome). If it is necessary to administer a large dose of levobupivacaine, for example, with epidural blockade, it is recommended to enter a preliminary test dose with 3-5 ml of lidocaine with epinephrine. Unintentional entry of the drug into the vascular bed can be recognized by a temporary increase in the heart rate, and accidental entry into the subshell - according to the symptoms of the spinal block.With prolonged (intermittent) administration of levobupivacaine through a catheter, an aspiration test (before the first and each subsequent additional injection) should be performed. Ingestion of the drug inside the vessel is possible even in the absence of blood in the syringe during the aspiration test. When performing epidural anesthesia, it is recommended first to enter a test dose and monitor the action of levobupivacaine before the entire preparation is administered.

Any local anesthetic for epidural administration can cause a decrease in blood pressure and a bradycardia. In this regard, all patients should be provided with venous access. It is also necessary to ensure the availability of appropriate solutions, vasopressors, anesthetics with anticonvulsant action, muscle relaxants, atropine and equipment for resuscitation (see "overdose" section).

Epidural analgesia

There are post-registration data on the development of horse tail syndrome and the appearance of signs of neurotoxicity (see the section "Side effects"), which were associated with the administration of levobupivacaine for epidural analgesia for 24 hours or more.When the drug was administered for more than 24 hours, such events were more severe, in some cases after them residual effects persisted. In this regard, the introduction of a drug lasting more than 24 hours should be carried out very carefully and only when the benefit to the patient significantly exceeds the risk.

With the administration of any local anesthetic, it is necessary to perform blood or cerebrospinal fluid aspiration (when necessary) before the injection of the main and each subsequent dose to avoid getting the drug into the lumen of the vessel or intrathecally. However, a negative aspiration test does not guarantee against getting the drug into the vascular bed or the subshell. In patients receiving other local anesthetics or drugs similar in structure to local anesthetics of the amide type, levobupivacaine should be used with caution because of the additive toxic effects of these medicines.

Regional blockade of large nerve trunks

In order to provide functional venous access, the patient must receive intravenous fluids through a permanent catheter.To ensure that a high concentration of the drug is not created in the blood plasma and serious unwanted reactions do not develop, the lowest dose of levobupivacaine should be used to achieve effective anesthesia. You can not inject large amounts of anesthetic with high speed, if possible, the drug should be injected fractionally, gradually increasing the dose.

Local anesthesia in the head and neck area

The administration of even small doses of levobupivacaine to the head and neck area (with retrobulbar blockade, blockade during dental procedures and blockade of the stellate ganglion) can cause severe undesirable reactions similar to such as systemic toxic effects after a random intravascular injection of the drug in a larger dose. The introduction of the drug requires extreme caution. Perhaps the development of reactions caused by intra-arterial injection of an anesthetic and its entry into the cerebral bloodstream by a retrograde route. Undesirable reactions can also be associated with puncture of the optic nerve dura during retrobulbar blockade with the diffusion of some local anesthetic through the subdural space into the midbrain.It is necessary to carry out constant monitoring and careful monitoring of respiratory and cardiac performance in patients who have these types of blockades. Also, equipment for resuscitation and staff with appropriate training should be available.

Application of the drug in surgical ophthalmology

Specialists who perform a retrobulbar blockade should remember the possibility of developing a stoppage of breathing with local administration of an anesthetic. As with other variants of regional anesthesia, before the retrobulbar blockade is performed it is necessary to make sure that equipment, personnel and medicines are available to treat disorders such as oppression or respiratory arrest, convulsions, agitation or suppression of cardiac activity. Like after other types of anesthesia, after retrobulbar blockade, constant monitoring is necessary to track the described adverse reactions.

Special patient groups

Use in weakened and elderly patients, as well as in patients with acute diseases

Levobupivacaine in attenuated and elderly patients, as well as in patients with acute diseases should be used with caution (see section "Method of administration and dose").

Impaired liver function

As levobupivacaine metabolized in the liver, patients with liver disease or with a decrease in hepatic blood flow (for example, with cirrhosis or alcoholic liver disease), the drug should be administered with caution (see section "With caution"),

This drug contains 3.6 mg / ml sodium, which should be considered when used in patients receiving a diet with a controlled sodium content.

Effect on the ability to drive transp. cf. and fur:

Levobupivacaine can have a significant effect on the ability to drive vehicles and work with mechanisms. It is necessary to warn patients about inadmissibility of management of vehicles and work with mechanisms before the resolution of all the effects of anesthesia and immediate effects of surgical intervention.

Form release / dosage:

Solution for injection, 5.0 mg / ml and 7.5 mg / ml.

Packaging:

10 ml in a polypropylene ampoule.

For 10 ampoules in a cardboard pack together with instructions for use.

Storage conditions:

At a temperature of 15 to 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-003106

Date of registration:21.07.2015 / 09.06.2016

Expiration Date:21.07.2020

The owner of the registration certificate:EbbVi Ltd.EbbVi Ltd. Russia

Manufacturer: & nbsp

Takеda Nycomed AS Norway

Representation: & nbspEbbVi Ltd.EbbVi Ltd.Russia

Information update date: & nbsp02.03.2017

Illustrated instructions

Instructions

Hirocain® (CHIROCAINE)