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

Excipients: sodium chloride - 8.0 mg, disodium edetate dihydrate (disodium ethylenediamine-N,N,N′,N'-tetraacetic acid 2-aqueous (Trilon B)) 0.1 mg, 1 M sodium hydroxide solution to pH 4.0-6.5, water for injection up to 1 ml.

Description:Pa clear, colorless solution.

Pharmacotherapeutic group:Local anesthetic

ATX: & nbsp

N.01.B.B.01 Bupivacaine

Pharmacodynamics:

The local anesthetic is a long-acting amide type, 4 times stronger than lidocaine. Being a weak lipophilic base, it penetrates through the lipid membrane of the nerve inside and, passing into the cationic form (due to a lower pH), inhibits the sodium channels, thereby reversibly blocking the impulse through the nerve fiber. Has hypotensive effect, slows heart rate.

Postoperative analgesia is maintained for 7-14 hours with intercostal blockade.

After a single epidural administration at a concentration of 5 mg / ml, the duration of the effect is 2 to 5 hours, and up to 12 hours - with peripheral nerve blockade.

Bupivacaine is a weak hyperbaric solution (in comparison with cerebrospinal fluid) at a temperature of 20 ° C and has the properties of a weak hypobaric solution at a temperature of 37 ° C. In general, the solution of the drug can be considered as isobaric, since gravity affects its distribution in the subarachnoid space.

The use of solutions at a concentration of 2.5 mg / ml has less effect on the motor nerves.

Pharmacokinetics:

Bupivacaine has a pKa value of 8.2, a separation factor of 346 (at 25 ° C in n-octanol / phosphate buffer solution pH 7.4).

Bupivacaine is completely absorbed into the blood from the epidural space, it is slowly and in small quantities absorbed from the subarachnoid space; the absorption is biphasic, the half-life for the two phases is 7 minutes and 6 hours, respectively. The slow elimination of bupivacaine is determined by the presence of a slow phase of absorption of the epidural space, which explains the longer half-life (T_1/2) after epidural administration compared with intravenous administration.

The total plasma clearance of bupivacin is 0.58 l / min, the volume of distribution in the equilibrium state is 73 liters, the final half-life is about 2.7 hours, the intermediate liver extraction index is about 0.38 after intravenous injection. Bupivacaine, mainly binds to alpha-acidic plasma glycoproteins (binding to plasma proteins - 96%).Bupivacaine clearance is almost entirely due to the metabolism of the drug in the liver and is more dependent on the activity of the liver's enzyme systems than on liver perfusion. Metabolites have less pharmacological activity than bupivacaine.

The plasma concentration of bupivacaine depends on the dosage of the drug, the method of administration of the drug, the vascularization in the area of administration.

In children aged 1 to 7 years, the pharmacokinetics of bupivacaine are similar to those in adults.

Penetrates through the placenta. The connection with plasma proteins in the fetus is lower than in the mother's body, the concentration of unbound fraction in the fetus and mother is the same. It is secreted with the mother's milk.

Bupivacaine is metabolized in the liver, mainly by aromatic hydroxylation to 4-hydroxy-bupivacaine and N-dealkylation to 2,6-pipecoloxylidine (RRB). Both reactions occur with the participation of cytochrome isoenzyme CYP3A4. About 1% of bupivacaine is excreted by the kidneys unchanged during the day after administration, and approximately 5% in the form of PPC. The concentration of PPC and 4-hydroxy-bupivacaine in plasma during and after prolonged administration of bupivacaine is low in relation to the administered dose of the drug.

In patients with liver disease, especially in patients with severe impairment of liver function, a higher risk of toxic reactions after application of local anesthetics of the amide type.

In elderly patients, the maximum analgesic and anesthetic effect occurs faster than in younger patients. Also in elderly patients there is a higher maximum concentration of bupivacaine in the blood plasma. The total plasma clearance in these patients is lowered.

Indications:

Surgical anesthesia in adults and children over 12 years.

Acute pain in adults and children over 1 year.

Infiltration anesthesia, when a long-term anesthetic effect is required, for example, in post-operative pain.

Conductive anesthesia with a prolonged effect or epidural anesthesia in cases where the addition of epinephrine is contraindicated and undesirable significant relaxation of the muscles.

Anesthesia in obstetrics.

Spinal anesthesia during surgical operations on the lower extremities, including operations on the hip joint, lasting 3-4 hours and not requiring a pronounced motor block.

Contraindications:

- Hypersensitivity to any of the components of the drug (including other amide local anesthetic drugs).

- diseases of the central nervous system (as in the epidural administration of other local anesthetics);

- severe arterial hypotension (cardiogenic or hypovolemic shock);

- paracervical blockade in obstetrics;

- contraindications to epidural anesthesia (coagulopathy, anticoagulant therapy, puncture skin infections, intracranial hypertension, hypovolemia, neurological diseases such as multiple sclerosis, meningitis, tumors, poliomyelitis, tuberculosis Heart disease with a fixed cardiac output (idiopathic hypertrophic Subaortic stenosis, aortic stenosis, mitral stenosis, complete AV-blockade, etc.). Anatomical abnormalities of the spine. Prophylactic use of low doses of heparin);

- children under 1 year.

The drug is not used for intravenous regional anesthesia (Bira blockade) (accidental penetration of bupivacaine into the bloodstream can cause the development of acute systemic toxic reactions).

Carefully:

Cardiovascular insufficiency (possibly progression), cardiac blockade, inflammatory diseases or infection of the injection site (for infiltration anesthesia), cholinesterase deficiency, renal failure, elderly age (over 65), pregnancy III trimester, general severe condition, decreased hepatic blood flow for example, with chronic heart failure, liver diseases), simultaneous administration of antiarrhythmic drugs (including beta-blockers), children's age from 1-12 years.

Simultaneous administration with local anesthetics or preparations structurally similar to local anesthetics of the amide type, such as antiarrhythmic drugs (eg, lidocaine, mexiletine).

Pregnancy and lactation:

The use of the drug is possible only in cases where the intended use for the mother exceeds the potential risk to the fetus.

Bupivacaine was used in a large number of pregnant women and women of childbearing age, but to date no specific changes in reproductive function in women of childbearing age and an increase in the frequency of developmental defects in the fetus have been noted.

The addition of epinephrine to bupivacaine can reduce blood flow in the uterus and its contractility, especially when the anesthetic solution is accidentally injected into the mother's vessels. With paracervical blockade, serious damage to the fetus from the side of the cardiovascular system is possible (the anesthetic reaches the fetus in high concentration).

Just like other anesthetics, bupivacaine can penetrate into breast milk in small amounts, not representing a danger to the child. Despite this, during the application of the drug, breastfeeding should be discarded.

Dosing and Administration:

Use Bupivacaine can only doctors who have experience in conducting local anesthesia or under their supervision. To achieve the required degree of anesthesia, the minimum possible dose should be administered.

Under no circumstances should you allow accidental intravascular drug administration. It is recommended to perform an aspirate test before and during the administration of the drug. The drug should be administered slowly, at a rate of 25-50 mg / min or fractional, maintaining continuous verbal contact with the patient and controlling the heart rate.During epidural administration, a dose of 3-5 ml of bupivacaine with epinephrine is preset. With a random intravascular injection, there is a short-term increase in the heart rate, with a random intrathecal injection, a spinal block appears. If there are toxic signs, the administration is immediately stopped.

Below are the estimated doses that need to be corrected depending on the depth of anesthesia and the patient's condition.

Infiltration anesthesia:

5-60 ml of the drug at a concentration of 2.5 mg / ml (12.5-150 mg bupivacaine) or 5-30 ml of the drug at a concentration of 5 mg / ml (25-150 mg bupivacaine).

Diagnostic and therapeutic blockade:

1-40 ml of the drug at a concentration of 2.5 mg / ml (2.5-100 mg bupivacaine), for example, trigeminal blockade of 1-5 ml of the drug (2.5-12.5 mg of bupivacaine) and cervico-thoracic sympathetic node 10-20 ml of the drug (25-50 mg of bupivacaine).

Intercostal blockade:

2-3 ml of the drug at a concentration of 5 mg / ml (10-15 mg bupivacaine), per nerve, not exceeding the total amount - 10 nerves.

Large blockades (eg, epidural block, blockade of the sacral or brachial plexus):

15-30 ml of the drug in a concentration of 5 mg / ml (75-150 mg of bupivacaine).

Anesthesia in obstetrics (eg, epidural and caudal anesthesia with natural delivery):

6-10 ml of the drug at a concentration of 2.5 mg / ml (15-25 mg of bupivacaine) or 6-10 ml of the drug at a concentration of 5 mg / ml (30-50 mg of bupivacaine).

After every 2-3 hours, repeated administration of the drug in the initial dose is allowed.

Epidural anesthesia with caesarean section:

15-30 ml of the drug in a concentration of 5 mg / ml (75-150 mg of bupivacaine).

Epidural analgesia in the form of intermittent bolus injection:

Initially, 20 ml of the drug are administered at a concentration of 2.5 mg / ml (50 mg of bupivacaine), then every 4 to 6 hours, depending on the number of damaged segments and the patient's age, 6-16 ml of the drug at a concentration of 2.5 mg / ml (15 -40 mg of bupivacaine).

Epidural analgesia in the form of continuous infusion (for example, postoperative pain):

Type of blockade	Concentration	Scope	Dose
Epidural introduction (at the lumbar level)
Bolus *	2.5 mg / ml	5-10 ml	12.5-25 mg
Infusion	2.5 mg / ml	5-7.5 ml / hr	12.5-18.75mg **
Epidural introduction (on thoracic level)
Bolus *	2.5 mg / ml	5-10 ml	12.5-25 mg
Infusion	2.5 mg / ml	2.5-5 ml / h	6.25-12.5 mg
Epidural introduction (natural childbirth)
Bolus *	2.5 mg / ml	6-10 ml	15-25 mg
Infusion	2.5 mg / ml	2-5 ml / hr	5-12.5 mg

* If during the previous hour the drug was not administered bolus.

** Do not exceed the maximum recommended daily dose (see below).

During the surgical intervention, additional administration of the drug is possible.

With the simultaneous use of narcotic analgesics, the dose of bupivacaine should be reduced.

With prolonged administration of the drug, the patient should regularly monitor blood pressure, heart rate and other signs of potential toxicity. If toxic effects occur, the drug should be discontinued immediately. Maximum recommended doses The maximum recommended single dose, calculated at 2 mg / kg body weight, is 150 mg for adults for four hours. This is equivalent to 60 ml of the drug at a concentration of 2.5 mg / ml (150 mg bupivacaine) and 30 ml drug at a concentration of 5 mg / ml (150 mg bupivacaine).

The maximum recommended daily dose is 400 mg. However, when calculating the total daily dose, it is necessary to take into account the patient's age, physique and other significant conditions.

Children aged 1-12 years

Regional anesthesia should be performed by a doctor who has experience working with children and who has the appropriate technique of administration.

Doses in children, given in the table, are indicative. Variability is possible. Children with high body weight, as a rule, need to reduce the dose, based on the ideal body weight. In determining the methods of anesthesia and taking into account the individual characteristics of patients should use the generally accepted guidelines for anesthesia.

It is necessary to enter the minimum dose necessary to achieve sufficient anesthesia.

	Concentration, mg / ml	Volume, ml / kg	Dose, mg / kg	Start of action, min	Aboutduration of action, hour
Sharp pain
Caudal epidural anesthesia	2,5	0,6-0,8	1,5-2	20-30	2-6
Lumbar epidural anesthesia	2,5	0,6-0,8	1,5-2	20-30	2-6
Thoracic epidural anesthesia^b	2,5	0,6-0,8	1,5-2	20-30	2-6
Regional blockade (eg, blockade and infiltration of small nerves)	2,5		0,5-2
	5		0,5-2
Blockade of peripheral nerves (for example, blockade of the iliac inguinal / ilio-hypogastric nerve)	2,5		0,5-2	a)
	5		0,5-2	a)

a) - the beginning and duration of peripheral nerve blockage depends on the nature of the blockade and dose

(b) - with thoracic epidural anesthesia, the drug is administered in ever increasing doses until the desired level of anesthesia is reached.

The dose in children is calculated based on 2 mg per kg of body weight.

In order to prevent the drug from entering the vascular bed, the aspiration test should be performed before and during the administration of the main dose. The drug should be administered slowly, dividing the total dose into several injections, especially with lumbar and thoracic epidural anesthesia, continuously observing the indicators of vital organs.

Peritonsillar infiltration anesthesia in children from 2 years of age: in a dose of 7.5 mg and 12.5 mg per tonsil with a concentration of bupivacaine 2.5 mg / ml.

Blockade of ilio-inguinal / ilio-hypogastric nerves in children from 1 year old: 0.1-0.5 ml / kg of body weight with a bupivacaine concentration of 2.5 mg / ml, equivalent to 0.25-1.25 mg / kg body weight.

Children aged 5 years and over the drug can be administered in a concentration of bupivacaine 5 mg / ml, equivalent to 1.25-2 mg / kg.

Blockade of the penis: 0.2-0.5 ml / kg with a bupivacaine concentration of 5 mg / ml, equivalent to 1.0-2.5 mg / kg.

Data on epidural anesthesia in children (bolus or continuous administration) are limited.

Cooking method

If a solution with a concentration of 2.5 mg / ml is required, it is possible to dilute the preparation at a concentration of 5 mg / ml only with compatible solvents,such as 0.9% sodium chloride solution for injection, since the properties of the preparation may change after dilution, which may lead to precipitation. Breeding should be carried out only by qualified personnel with mandatory visual control before use. It is possible to use only clear solutions without visible particles.

The drug solution is intended for single use only.

With intrathecal administration

Use bupivacaine can only doctors who have experience in conducting local anesthesia or under their supervision. To achieve the required degree of anesthesia, the minimum possible dose should be administered. The doses given below are adults. Selection of the dose is carried out individually.

Elderly patients and patients in late pregnancy should reduce the dose.

Indications for use	Dose, ml	Dose, mg	Start of action	Duration of action
Surgical operations on the lower extremities, including operations on the hip joint	2-4 ml	10-20 mg	5-8 min	1,5-4 hours

The recommended injection site is at the level of L3.

Clinical experience with doses exceeding 20 mg is not available.

Prior to the administration of the drug, intravenous access should be provided. The introduction is carried out only after confirmation of the entry into the subarachnoid space (the flow out of the needle of the transparent cerebrospinal fluid or during aspiration). If an unsuccessful attempt is made, only one additional attempt should be made at a different level and less. One of the reasons for the lack of effect can be a poor distribution of the drug in the subarachnoid space, which can be corrected by changing the patient's position.

Children with body weight less than 40 kg

Bupivacaine injection for 5 mg / ml is allowed in children. The main difference between adults and children is that in newborns and infants the volume of cerebrospinal fluid is greater, that to achieve the same degree of blockade requires a relatively high dose per kilogram of body weight in comparison with adults.

Regional anesthesia should be performed by a doctor who has experience working with children and who has the appropriate technique of administration.

Doses in children, given in the table, are indicative. Variability is possible. When definingAnaesthesia guidelines should be used in patients with anesthesia and individual patient characteristics. It is necessary to enter the minimum dose necessary to achieve sufficient anesthesia.

Body weight, kg	Dose, mg / kg
<5	0,4-0,5
5-15	0,3-0,4
15-40	0,25-0,3

Side effects:

Adverse reactions caused by the drug are difficult to distinguish from the physiological manifestations of nerve blockade (eg, arterial hypotension, bradycardia, temporary urinary retention), reactions caused directly (eg, spinal hematoma) or indirectly (eg, meningitis, epidural abscess) by insertion of a needle, or reactions caused by leakage of spinal fluid (eg, post-puncture headache).

The undesirable effects listed below are given in accordance with the following gradations of their occurrence frequency:

Very frequent - 1/10 appointments (≥ 10%);

Frequent - 1/100 appointments (≥ 1% and <10%);

Infrequent - 1/1000 appointments (≥ 0.1% and <1%);

Rare - 1/10000 appointments (≥ 0.01% and <0.1%);

From the central and peripheral nervous system: often - parasthesia, dizziness; infrequently - cramps, paresthesia around the mouth, numbness of the tongue, hyperacia,light dizziness, visual disturbances, loss of consciousness, tremor, noise and ringing in the ears, dysarthria; rarely - an unintended total spinal block, peripheral nerve damage, paraplegia, paralysis, neuropathy, arachnoiditis.

From the cardiovascular system: very often - hypotension; often bradycardia, increased blood pressure; rarely - cardiac arrest, arrhythmia.

From the digestive system: very often - nausea; often - vomiting.

From the urinary system: often urinary retention, incontinence.

From the respiratory system: rarely - respiratory depression.

From the sense organs: rarely - diplopia.

Are common: rarely - allergic reactions, in the most severe cases - anaphylactic shock.

Overdose:

Acute systemic intoxication

In case of accidental intravascular injection, a toxic reaction occurs within 1-3 min, while in case of an overdose, maximum concentrations of bupivacaine in the blood plasma can be achieved within 20-30 min, depending on the injection site, with signs of intoxication appearing slowly. Toxic reactions are manifested mainly from the central nervous and cardiovascular system.

From the central nervous system Intoxication manifests itself gradually in the form of signs of impaired central nervous system functions with a growing degree of severity. The first symptoms, as a rule, are manifested in the form of paresthesia around the mouth, minor dizziness, numbness of the tongue, pathologically increased perception of sounds and noise in the ears. Disturbance of vision and tremor are the most serious signs and precede the development of generalized seizures. These symptoms should not be regarded as neurotic behavior. Following them, loss of consciousness and the development of large seizures can occur from a few seconds to several minutes. During convulsions, oxygen deficiency and hypercapnia develop rapidly due to increased muscular activity and insufficient gas exchange in the lungs. In severe cases, apnea may develop. Acidosis increases the toxic effect of local anesthetics. These phenomena are due to the redistribution of local anesthetic from the central nervous system and the metabolism of the drug. Catching of toxic effects can occur quickly, except when a very large amount of the drug has been administered.

From the side of the cardiovascular system

Toxic effect on the cardiovascular system is observed in severe cases. He, as a rule, is preceded by manifestations of a toxic effect on the central nervous system. In patients who are in a state of deep sedation or general anesthesia, prodromal neurologic symptoms may be absent. Against the background of high systemic concentrations of bupivacaine in the plasma, hypotension, disturbance of myocardial conductivity, a decrease in the minute volume of the heart, AV-blockade, bradycardia, ventricular arrhythmia (up to cardiac arrest). In a number of rare cases, cardiac arrest occurs without prodromal neurologic events.

In children with a blockade under general anesthesia, it is difficult to notice early signs of the toxic effect of an anesthetic.

Treatment of acute intoxication

When there are signs of general intoxication, it is necessary to stop the drug immediately. Therapy should be aimed at maintaining ventilation of the lungs, arresting seizures and maintaining blood circulation. It should be used oxygen and if necessary, establish artificial ventilation of the lungs (using a mask and a bag).

If seizures do not stop on their own within 15-20 seconds, intravenous anticonvulsants should be administered. Intravenous injection of 100-150 mg of thiopental sodium quickly cures convulsions, instead of it, 5-10 mg of diazepam is administered intravenously, although it acts more slowly. Suxamethonium quickly suppresses muscle cramps, however, it requires intubation of the trachea and artificial ventilation of the lungs, so this medication should be used only by those who own these methods.

With obvious oppression of the cardiovascular system (lowering blood pressure, bradycardia) intravenously administered 5-10 mg of ephedrine, if necessary, after 2-3 min, the administration is repeated. At a cardiac arrest immediately proceed to cardiopulmonary resuscitation. It is vitally important to optimize oxygenation and ventilation and maintain circulation along with correction of acidosis, since hypoxia and acidosis will intensify the systemic toxic effects of the local anesthetic. It should be introduced as soon as possible epinephrine (0,1-0,2 mg intravenously or intracardiac), if necessary, the administration should be repeated.

When cardiac arrest may require prolonged resuscitation.

Interaction:

Local anesthetics or preparations similar in structure to local anesthetics of the amide type, such as antiarrhythmics Ib class (lidocaine, mexiletine) increase the risk of developing an additive toxic effect.

The combined use of bupivacaine with antiarrhythmic drugs III-class (eg, amiodarone) have not been studied separately, but it is recommended to be careful while appointing these drugs (see. Section "Special instructions").

Monoamine oxidase inhibitors or tricyclic antidepressants increase the risk of a marked increase in blood pressure.

Preparations containing oxytocin or ergotamine, promote the development of a steady increase in blood pressure with possible complications from the cardiovascular and cerebrovascular system.

The combination with total inhalation anesthesia halothane increases the risk of arrhythmia.

When treating the site of injection of a local anesthetic with disinfectant solutions containing heavy metals, the risk of developing a local reaction in the form of soreness and edema increases.

Preparations structurally similar to local anesthetics, for example, toxainide, increase the risk of developing an additive toxic effect.

Local anesthetics increase the inhibition of the central nervous system, caused by drugs that depress the central nervous system.

The solubility of bupivacaine decreases at pH> 6.5, this should be taken into account if alkaline solutions are added, since a precipitate may form.

Special instructions:

There are reports of cardiac arrest or death while using bupivacaine for epidural anesthesia or peripheral blockade. In some cases, resuscitation was difficult or impossible, despite the undoubtedly good preparation and anesthesia.

Like other local anesthetics, bupivacaine can cause acute toxic reactions from the central nervous and cardiovascular systems, if its use for local anesthesia leads to a high concentration of the drug in the blood. Most often this is manifested in the case of unintentional intravascular injection or with high vascularization of the site of administration.

Against the background of a high concentration of bupivacaine in the plasma, cases of ventricular arrhythmia, ventricular fibrillation, sudden cardiovascular collapse and death were documented.

Regional anesthesia should be carried out by experienced specialists in an appropriately equipped room with availability of ready-to-use equipment and preparations necessary for cardiac monitoring and resuscitation. When performing large blockades before the introduction of a local anesthetic, it is recommended to install an intravenous catheter. Staff should undergo appropriate training in the technique of anesthesia and should be familiar with the diagnosis and treatment of the side effects of the drug, systemic toxic reactions and other complications (see "Overdose").

The peripheral nerve blockade is associated with the introduction of a larger volume of local anesthetic into the region of high vascularization, often close to large vessels, where the risk of unintentional intravascular injection of local anesthetic or systemic absorption of a large dose of the drug increases, which in turn can lead to an increase in plasma concentration.

When conducting regional anesthesia, you should be especially attentive to the following groups of patients:

- Patients receiving antiarrhythmic drugs IIIth class (for example, amiodarone), should be carefully monitored, because of the possible risk of complications from the cardiovascular system.

- Older patients and weakened patients.

- Patients with partial or complete cardiac blockade, since local anesthetics can impair myocardial conductivity.

- Patients with progressive liver disease or with severe renal dysfunction.

- Patients in late pregnancy.

Certain types of blockades, regardless of the local anesthetic used, can be associated with serious adverse reactions, for example:

- Central blockades, especially against the background of hypovolemia, can lead to inhibition of the cardiovascular system.

- Large peripheral blockages may require the use of a large amount of local anesthetic in areas of high vascularization, often near large vessels, where the risk of intravascular administration and / or systemic absorption increases, which can lead to a high concentration of the drug in the plasma.

- With retrobulbar injection, the drug can accidentally enter the cranial subarachnoid space, causing temporary blindness, apnea, convulsions, collapse and other side effects. Developed complications should be timely diagnosed and stopped.

- With retrobulbar and peribulbar injection of local anesthetics, there is a small risk of permanent damage to the function of the eye muscles. The main causes are trauma and / or local toxic effects on muscles and / or nerves. The severity of these tissue reactions depends on the degree of injury, the concentration of the local anesthetic and the duration of exposure of the tissue with a local anesthetic. Therefore, as with other local anesthetics, the lowest effective concentration and dose of the drug should be used. Vasoconstrictors can enhance tissue reactions and should be used only on indications.

- When injected into the neck or head, the drug may accidentally enter the artery, and in these cases, even with low doses, serious adverse reactions may develop.

- During epidural anesthesia hypotension and bradycardia may occur.Reducing the likelihood of these complications can be done by first introducing crystalloid and colloidal solutions. With the development of hypotension, immediately introduce sympathomimetics intravenously; If necessary, their introduction should be repeated. In children, the doses used should be appropriate for age and weight.

In the case of a salt-free diet with a limited intake of it, the sodium of the drug should be taken into account, since the preparation contains sodium ions.

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

Information on the use of the drug in children:

The safety and effectiveness of bupivacaine in children younger than 1 year have not been studied, only limited data are available.

Data on the intra-articular blockade of bupivacaine in children 1-12 years are absent.

Data on the bupivacaine blockade of large nerves in children 1-12 years are absent.

With epidural anesthesia, the drug should be administered slowly, guided by age and body weight, since especially with epidural anesthesia at the breast level severe hypotension and respiratory failure can occur.

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

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Solution for injection, 5 mg / ml.

Packaging:

By 4, 10, 20 ml into ampoules of colorless glass.

5 ampoules are placed in contoured cell packs from a polyvinyl chloride film and foil of aluminum printed lacquered or foil-free.

1, 2 contour mesh packages are placed in packs of cardboard.

Each instruction pack or box is supplied with instructions for use, the ampoule scaler. Ampoule scapper does not invest when using ampoules with a kink ring or with an incision and a point.

To 20 ml in bottles of colorless glass.

5 bottles are placed in boxes of cardboard.

5 bottles are placed in contour mesh packaging from polyvinyl chloride film and aluminum foil printed lacquered or foil-free.

1 contour mesh package is placed in a pack of cardboard.

Each instruction pack or box is supplied with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C.Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002824

Date of registration:15.01.2015 / 15.08.2016

Expiration Date:15.01.2020

The owner of the registration certificate:VELFARM, LLC VELFARM, LLC Republic of San Marino

Manufacturer: & nbsp

SYNTHESIS, OJSC Russia

Representation: & nbspSYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products SYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products Russia

Information update date: & nbsp20.04.2017

Illustrated instructions

Instructions

Bupivacaine (Bupivacaine)