Anesthesia, intrathecal in adults before surgery, short duration (see Dosage and Mode of Administration)

Reserved for hospital use.

Intrathecal anesthesia must be performed exclusively by or under the supervision of a specialist physician who has knowledge and experience of the intrathecal anesthesia technique (see section 4.4, "Warnings and Precautions for Use"). Code>
The equipment, medicines, and skilled personnel to take charge of an emergency, including ensuring the maintenance of the airway's permeability and administering oxygen, must be available immediately as, in rare cases Severe, sometimes fatal, reactions have been described following the use of local anesthetics even in the absence of a history of individual hypersensitivity in the patient.

In case of signs of acute or complete spinal block toxicity, local anesthetic injection should be discontinued immediately (see Warnings and Precautions for Use). >

Dosage

The dosage should be determined individually according to the specific characteristics of the patient. When determining the dose, consideration should be given to the physical condition of the patient and the concomitant administration of other drugs. The lowest dose needed to produce an effective block should be used.
The duration of action is dose-dependent.

The doses below are recommended in adult patients of an average size and weight (about 70 kg) to obtain an effective block in single administration. As far as intensity and duration of action are concerned, considerable individual variations are observed. The experience of the anesthetist and the knowledge of the general condition of the patient are essential elements for the determination of the dose.

Dosage recommendations are the following

Dosage in adults

Level of the required sensory block T10

Ml

Mg

Average duration of action (minutes)

42431

40-60

Approximately 100-130

The maximum recommended dose is 80 mg of prilocaine hydrochloride ('= 4 ml of BARITEKAL).
Population, pediatric

The efficacy and safety of BARITEKAL in the pediatric population have not been evaluated. No data is available.

The use of BARITEKAL is not recommended in children and adolescents

The use of BARITEKAL in children younger than six months is contraindicated (see section Contraindications).


It is advisable to decrease the dose in patients whose general condition is altered.
If the patient has impaired hepatic or renal function, it is advisable to administer a lower dose.


Due to the presence of glucose, BARITEKAL should be used only by intrathecal route. The use of BARITEKAL is not recommended by the epidural route.
Injection of intrathecal BARITEKAL in the intervertebral spaces L2 / L3, L3 / L4 and L4 / L5
The intrathecal injection should be performed slowly after a minimal amount of cerebrospinal fluid has been aspirated to ensure proper positioning of the needle while closely monitoring the vital functions of the patient and maintaining contact With this one.

In case of signs of acute or complete spinal block toxicity, local anesthetic injection should be discontinued immediately (see Warnings and Precautions for Use). If the patient is in a sitting position, the injected solution diffuses mainly in the caudal direction (in the direction of the sacrum). If the patient is in the supine position, the anesthetic diffuses by gravity according to the position of the patient (Trendelenburg and anti-Trendelenburg).
The density of BARITEKAL, by the presence of glucose as an excipient, is 1.026 g / g at 20 ° C., equivalent to 1.021 g / g at 37 ° C.

Clear solution colorless.

Pharmacotherapeutic class: anesthetics, local, amides. ATC code: N01BB04

Prilocaine is a local amide anesthetic. Prilocaine inhibits excitable structures (eg all types of fibers, nerves [sensory, motor, autonomic nervous fibers]). It blocks the excitability of sensory receptors, pain and conduction of nerve fibers, sensory, locally and reversibly, reducing the perception of pain, and hence the cold, Heat, touch and pressure.

Prilocaine reduces membrane permeability to sodium This reduces the excitability of the nerve fibers as a function of the dose administered by reducing the peak sodium permeability necessary for the formation of the action potentials The effect depends on the pH of the substance and the pH of the environment. The effect of the local anesthetic is due to the protonated form. In inflamed tissues, the effect of local anesthetics is lower because of the low pH of the environment.

When using BARITEKAL, it is the responsibility of the doctor to decide, for each case, whether the patient can drive or use machines.

BARITEKAL should not be used in patients with

· Hypersensitivity to prilocaine hydrochloride, to other amide-type local anesthetics, or to any of the excipients mentioned under section
· Severe abnormalities of cardiac conduction

· Severe anemia

· Decompensated heart failure

· Cardiogenic and hypovolemic shock

· Congenital or acquired methaemoglobinemia

· Concurrent treatment with anticoagulants

· General and specific contraindications to anesthesia, spinal technique.

The use of BARITEKAL in children under six months is contraindicated because of the increased risk of developing methemoglobinemia.
Intravascular injection of BARITEKAL is contraindicated. BARITEKAL should not be injected into infected areas.

BARITEKAL, containing glucose, it should be used only by intrathecal route. BARITEKAL is not recommended for epidural use

BARITEKAL can potentiate the formation of methaemoglobin by known drugs, to increase methemoglobin (see section Interactions with other medicinal products and other forms of interactions). >
Intrathecal anesthesia must be performed exclusively by specialized medical personnel (or under its supervision), with the necessary knowledge and experience. It is the responsibility of the physician in charge to take the necessary measures to avoid intravascular injection.
In addition, it is essential that the physician is able to identify and treat adverse reactions, systemic toxicity, and other complications. In case of signs of acute systemic toxicity or complete spinal block, local anesthetic injection should be discontinued immediately (see section Overdose). >
Some patients require special attention to reduce the risk of serious adverse reactions even when locoregional anesthesia is the optimal choice for surgery

· Patients with a total or partial branch block because local anesthetics are likely to suppress myocardial conduction

Patients with severe cardiac decompensation. The risk of methaemoglobinemia should also be taken into account (see section 4.4).
· Patients with severe liver or kidney disease

· Elderly patients and patients whose condition is altered.

· Patients treated with class III antiarrhythmics (eg amiodarone). These patients should be carefully monitored and monitored by electrocardiography because cardiac effects may be added (see Interactions with other drugs and other forms of interaction).

· In patients with acute porphyria, BARITEKAL should be used only as an absolute indication of its use because BARITEKAL is potentially capable of aggravating porphyria. Appropriate precautions should be taken in all patients with porphyria

It is mandatory to ensure the presence of a functional venous approach.
As with all local anesthetics, a fall in blood pressure may occur and the heart rate may slow down.

In patients at high risk, the recommendation is to improve the general condition before the procedure.

A rare but serious adverse effect of intrathecal anesthesia is a high or total spinal block with consequent depression, cardiovascular and respiratory. Cardiovascular depression is induced by a prolonged blockade of the sympathetic nervous system which can induce severe hypotension and bradycardia, which may go as far as cardiac arrest. Respiratory depression is induced by the blockage of the respiratory muscles and the diaphragm

Especially in elderly patients and patients in the last period of pregnancy there is an increased risk of block, high or total spinal: it is therefore recommended to reduce the dose of anesthetic

Especially in elderly patients, an unexpected drop in blood pressure is a potential complication of intrathecal anesthesia.

In rare cases, neurological damage may occur after anesthesia, intrathecal. They are manifested by paraesthesias, loss of sensibility, weakness, motor and paralysis. Occasionally, these symptoms may be persistent.

There is no reason to suspect that neurological disorders such as multiple sclerosis, hemiplegia, paraplegia, or neuromuscular disorders may be aggravated by intrathecal anesthesia. However, this type of anesthesia should be used with caution A careful evaluation of the benefit-risk ratio is recommended before treatment.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose (the maximum dose is 4 ml of BARITEKAL), ie it is considered to be 'sodium-free'.

BARITEKAL can potentiate the formation of methaemoglobin by drugs, increasing methemoglobin (eg, sulfonamides, antimalarials, sodium nitroprusside and nitroglycerin)

In the case of concomitant use of BARITEKAL with other local anesthetics or medicaments having a chemical structure similar to that of BARITEKAL (for example certain antiarrhythmics such as apridine, lidocaine, mexiletine and tocainide) , Undesirable effects can add up.
There have been no studies on the interactions between prilocaine and class III antiarrhythmics (eg amiodarone) but caution is also necessary in this case (see also Warnings and Precautions). , Precautions for use).

The combination of several local anesthetics leads to an accumulation of effects which affect the cardiovascular system and the central nervous system.
In the absence of compatibility studies, this drug should not be mixed with other medicines.
This medicinal product must not be administered if it is found that the solution is not clear and free of particles.

It is unlikely that BARITEKAL, at recommended doses, will lead to plasma levels capable of causing systemic toxicity

Acute systemic toxicity

The systemic adverse effects which may occur in the presence of a plasma prilocaine level greater than 5-10 micrograms are of iatrogenic, pharmacodynamic or pharmacokinetic origin and affect the central and cardiovascular nervous systems.

Iatrogenic adverse reactions can occur

· Following the injection of an excessive amount of solution

· Following an accidental injection, intravascular

· Because of incorrect positioning of the patient

· Following a high intrathecal anesthesia (marked decrease in blood pressure).

In case of accidental intravenous injection, the toxic effect appears within 1 to 3 minutes. In contrast, in the event of overdose, maximum plasma concentrations are reached within 20 to 30 minutes, depending on the site of injection, and the onset of signs of toxicity is delayed. >

Signs of overdose may be classified into two distinct symptom groups that differ in identity and intensity

A) Symptoms affecting the central nervous system

In general, the first symptoms are paresthesias of the region, buccal, numbness of the tongue, sensation of stupor, hearing problems and tinnitus. Visual disorders and muscular contractions are more severe and precede generalized convulsions. These signs should not be mistakenly confused with psychiatric manifestations (neuroses). Loss of consciousness and a tonic-clonic attack may occur, and usually last from a few seconds to a few minutes. Convulsions are immediately followed by hypoxia and an elevated concentration of carbon dioxide in the blood (hypercapnia), due to an increase in muscle activity associated with respiratory disorders. In severe cases, respiratory arrest may occur. Acidosis potentiates the toxic effects of local anesthetics

The reduction or improvement of symptoms affecting the central nervous system may be attributed to the redistribution of the local anesthetic outside the central nervous system, with consequent metabolism and excretion. The regression of symptoms may be rapid, unless the quantities used are very important.

B) Symptoms, cardiovascular

In severe cases, cardiovascular toxicity is likely to occur. Hypotension, bradycardia, arrhythmias and even cardiac arrest may occur in the presence of a high systemic concentration of local anesthetics.
The first signs of toxicity affecting the central nervous system generally precede those of the cardiovascular system. This statement is not valid if the patient is under general anesthesia or under heavy sedation by drugs such as benzodiazepines or barbiturates.
Treatment of systemic toxicity, acute

The following measures should be taken immediately:

· Stop the administration of BARITEKAL.

· Ensure adequate oxygenation: maintain airway permeability, administer O 2, introduce artificial ventilation (intubation) if necessary
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In case of cardiovascular depression, the circulation must be stabilized. If convulsions occur and do not resolve spontaneously after 15 to 20 seconds, administration of an intravenous anticonvulsant is recommended.
Central analeptics are contraindicated in cases of poisoning by local anesthetics.

In case of serious complications, during the treatment of the patient, it is advisable to have the assistance of a doctor specializing in emergency medicine and resuscitation (eg an anesthetist).

Methemoglobinemia

Methemoglobinemia may occur following administration of prilocaine BARITEKAL is contraindicated in locoregional anesthesia techniques requiring continuous administration. The doses used for spinal anesthesia can not induce blood levels capable of causing methemoglobinemia, which occurs if the amount of prilocaine hydrochloride administered is equal to or greater than 600 Mg.

A metabolite of prilocaine, o-toluidine, can lead to the formation of methaemoglobin. In general, the formation of methaemoglobin is clinically negligible except in cases of severe anemia and severe cardiac decompensation

Patients with severe anemia may develop hypoxia. It is important to exclude other serious causes of cyanosis, eg, acute hypoxia and / or heart failure.

Treatment of methemoglobinemia

Measured methemoglobinemia was resolved 15 minutes after I.V. injection of 2-4 mg / kg of toluidine blue.

Further information

Even low concentrations of methemoglobin may alter pulsoxymmetric measurements.

Fertility

No data in humans are available regarding the effect of prilocaine on fertility. Prilocaine has no effect on the fertility of male and female rats (see section Preclinical safety data).
Pregnancy

No adequate data are available on the use of prilocaine during pregnancy. Prilocaine can pass the placental barrier

Cases of neonatal methaemoglobinaemia requiring treatment have been reported after use of prilocaine in the context of obstetric use in order to perform a paracervical block or pudendal anesthesia.

Cases of fetal bradycardia causing death have occurred with other local amide anesthetics following a paracervical block.



It is not known whether prilocaine is eliminated in human milk. If its use is required during lactation, breastfeeding may be resumed approximately 24 hours after treatment.
The potential undesirable effects associated with the use of BARITEKAL are generally similar to those of other local anesthetics of the amide group during intrathecal anesthesia.Adverse effects induced by the drug are difficult to distinguish from the effects (Eg, pressure drop, arterial pressure, bradycardia, urinary retention, temporary), direct effects (eg hematoma, spinal) or indirect effects (eg meningitis) of the injection or Effects due to loss of fluid, cerebrospinal fluid (eg headache, after intrathecal anesthesia)

The frequency of the undesirable effects listed below is defined according to the following convention: very common (≥ 1/10), frequent (≥ 1/100 to;

In addition, following inhibition or blockade of the cardiac conduction system, heart rate may slow down and myocardial depression may occur.

All disorders related to the metabolism (liver) or excretion (kidney) of BARITEKAL should also be considered as other possible causes, as well as adverse effects.

Reporting of suspected adverse reactions

The reporting of suspected adverse effects after authorization of the drug is important. It provides continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers -
Anesthesia, intrathecal in adults before surgery, short duration (see Dosage and Mode of Administration)