MEPIVACAINA 10 mg /Ml Roztwór Do Wstrzykiwań

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1. Mepivacaina Recordati 10 mg/ml Injectable Solution, 20 mg/ml Injectable Solution
   1. What is Mepivacaina Recordati and what it is used for
   2. What you need to know before using Mepivacaina Recordati
   3. How to use Mepivacaina Recordati
   4. Possible side effects
   5. How to store Mepivacaina Recordati
   6. Package Contents and Other Information
2. Mepivacaine must be used with caution in patients undergoing treatment with other local anesthetics

Mepivacaina Recordati 10 mg/ml Injectable Solution, 20 mg/ml Injectable Solution

mepivacaine hydrochloride

Generic medicine

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Mepivacaina Recordati is and what it is used for
• 2. What you need to know before using Mepivacaina Recordati
• 3. How to use Mepivacaina Recordati
• 4. Possible side effects
• 5. How to store Mepivacaina Recordati
• 6. Contents of the pack and other information

1. What is Mepivacaina Recordati and what it is used for

Mepivacaina Recordati contains the active ingredient mepivacaine hydrochloride which belongs to
a class of medicines called local anesthetics - amides that cause loss of sensitivity
in the area of the body affected by the treatment.

Mepivacaina Recordati is indicated in all interventions concerning:

• General surgery (minor surgery)
• Pregnancy, childbirth and female genital apparatus (obstetrics and gynecology)
• Urinary system (urology)
• Eyes (ophthalmology, for example retrobulbar block, etc.)
• Skin (removal of warts, dermoid cysts, etc.)
• Nose, mouth and throat (tonsillectomy, rhinoplasty, middle ear surgery, etc.)
• Bones and joints (reduction of fractures and dislocations, etc.)
• General medicine (severe pain, pain due to nerve injury, etc.)
• Sports medicine (muscle tears, meniscus injuries, etc.)
• Teeth and mouth (tooth extractions, dental and gum surgery, conservative and prosthetic therapy, etc.).

2. What you need to know before using Mepivacaina Recordati

Do not use Mepivacaina Recordati

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to other local anesthetics of the same class as mepivacaine or to other similar substances
• if you suffer from a blood disease called porphyria
• if you suffer from epilepsy
• if you suffer from coagulation disorders
• if you have severe heart rhythm disturbances (atrioventricular conduction not controlled by a pacemaker)
• if you are pregnant or suspect you may be pregnant.

Mepivacaina Recordati should not be administered to children undergoing
surgical procedures on teeth and mouth and to newborns (see “How to use Mepivacaina
Recordati”)

Warnings and precautions
Consult your doctor, pharmacist or nurse before using Mepivacaina Recordati.
The doctor will verify your physical condition before starting treatment.
The medicine will always be administered in adequately equipped areas and by
qualified personnel, except in cases involving extremely simple administration
techniques.
Some local anesthesia techniques may be associated with severe adverse reactions,
regardless of the local anesthetic used, such as:

• reduction of cardiovascular function;
• in very rare cases (during injections into the eyeball), temporary blindness, cardiovascular collapse, respiratory arrest (apnea), convulsions, etc.;
• a low risk of prolonged muscle dysfunction at the level of the eyes (during injections into the eyeball);
• reduction of blood pressure (hypotension) and heart rate (bradycardia);
• Mepivacaina Recordati is contraindicated in labor and delivery as it passes through the placenta with potential toxic effects on the fetus and newborn.

To reduce the risk of dangerous side effects, the doctor will pay close attention if:

• you suffer from advanced liver disease or severe kidney dysfunction;
• you suffer from a partial or complete heart block;
• you are elderly or in poor general condition;
• you are taking medicines that regulate heart rhythm (class III antiarrhythmics, e.g. amiodarone), in these cases the doctor will subject you to numerous checks and assess whether to perform an electrocardiogram.

If you are in poor general condition due to age or other factors such as serious problems with the
heart, liver or severe kidney dysfunction, the doctor will pay particular
attention, even though local anesthesia frequently represents the
best anesthetic technique in these cases.
At the recommended doses, the medicine does not significantly or for a long time affect
attention capacity.

Other medicines and Mepivacaina Recordati
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Tell your doctor if you are taking other local anesthetics, antiarrhythmics (such as mexiletine and
amiodarone) or medicines against depression (MAOIs or tricyclic antidepressants) as in
these cases maximum caution will be taken when administering Mepivacaina Recordati.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before using
this medicine.

Pregnancy
The medicine is contraindicated in established or suspected pregnancy (see
“Contraindications”).
Mepivacaine will not be administered during labor and delivery as it is
contraindicated (see “Warnings and precautions”).

Breastfeeding
Mepivacaine will not be administered during breastfeeding.

Driving and operating machinery
Mepivacaina Recordati may temporarily negatively affect movements and
level of alertness. Be careful before driving vehicles and operating
machinery.

3. How to use Mepivacaina Recordati

Use this medicine following exactly the instructions of the doctor or the
pharmacist. If you have any doubts, consult your doctor or pharmacist.
The dose will be established by the doctor.

Use in children
Newborns
Mepivacaina Recordati must not be used in newborns. (see “Contraindications”).

Children
Do not use in children who are to undergo surgical procedures on teeth and mouth
(see “Contraindications”).

Hepatic insufficiency
If you suffer from liver problems, the dose does not need to be reduced for surgical anesthesia.
When prolonged blocks are used, your doctor will establish the dose based on the
classification of your disease.

Renal insufficiency
If you suffer from kidney problems, the dose does not need to be reduced for surgical anesthesia up to
24 hours

If you use more Mepivacaina Recordati than you should
Accidental injection into the vessels of local anesthetics can cause immediate toxic reactions
involving the whole body (from a few seconds to a few
minutes). In case of overdose, toxicity manifests later, 15-60 minutes after
the injection, (see “Possible side effects”).
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
With Mepivacaina Recordati, toxic and allergic reactions may occur. Among the
toxic reactions reported are:
excitation, tremors, disorientation, dizziness, dilation of the pupil (mydriasis), increased
metabolism and body temperature, and, for very high doses, contraction of the
muscles of the jaw (trismus) and convulsions, sweating, alteration of heart rhythm
(arrhythmias), increased blood pressure (hypertension), increased respiratory rate (tachypnea), dilation of the bronchi (bronchodilation), nausea and vomiting,
slowing of the heartbeat (bradycardia) and vasodilation.
Allergic reactions can occur in both predisposed and non-predisposed individuals. Allergic manifestations include:
various types of skin rashes, urticaria, itching; bronchospasm, swelling of the throat
(laryngeal edema), heart and lung collapse (cardiorespiratory from anaphylactic shock).
Undesirable effects of the medicine
Common (may affect up to 1 in 10 people)

• decrease in blood pressure (hypotension) (more frequent after epidural block)
• increase in blood pressure (hypertension)
• nausea (more frequent after epidural block)
• vomiting (more frequent after epidural block)
• altered sensitivity in the limbs and other parts of the body (paresthesia)
• dizziness
• slowing of the heartbeat (bradycardia)

Uncommon (may affect up to 1 in 100 people)

• convulsions
• altered sensitivity around the mouth (circumoral paresthesia)
• numbness of the tongue
• hypersensitivity to sounds (hyperacusis)
• visual disturbances
• loss of consciousness
• tremor
• ringing in the ears (tinnitus)
• speech disorders (dysarthria)
• depression of the nervous system

Rare (may affect up to 1 in 1,000 people)

• cardiac arrest
• irregular heartbeat (cardiac arrhythmias)
• allergic reactions
• severe and sudden allergic reaction (anaphylactic shock)
• difficulty breathing (respiratory depression)
• nerve damage (neuropathy)
• peripheral nerve damage
• inflammation of one of the membranes of the brain (arachnoiditis)
• double vision (diplopia)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
please inform your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5. How to store Mepivacaina Recordati

Store at a temperature below 30°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after
“Expiry”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Mepivacaina Recordati Contains

• The active ingredient is mepivacaine hydrochloride.

1 ml of Mepivacaina Recordati 10 mg/ml contains 10 mg of mepivacaine hydrochloride. 1
ml of Mepivacaina Recordati 20 mg/ml contains 20 mg of mepivacaine hydrochloride.

• The other ingredients are: sodium chloride, water for injections.

Description of the appearance of Mepivacaina Recordati and contents of the pack
Mepivacaina Recordati 10 mg/ml injectable solution 10 vials of 10 ml
Mepivacaina Recordati 20 mg/ml injectable solution 10 vials of 5 ml
Mepivacaina Recordati 20 mg/ml injectable solution 10 vials of 10 ml

Marketing Authorisation Holder
Recordati Industria Chimica Farmaceutica S.p.A. - via M. Civitali, 1 - 20148 Milan

Manufacturer
Istituto Biochimico Nazionale Savio s.r.l. – via E. Bazzano, 14 – 16019 Ronco Scrivia (GE)
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The following information is intended exclusively for doctors or healthcare professionals:

Warnings and Precautions
Immediate availability of equipment and medicines
necessary for emergency resuscitation monitoring is required.
In patients undergoing major block or receiving high doses of the medicine, a
venous catheter must be inserted before administration of the local anesthetic. The doctor must have undergone complete and adequate training in the type of
technique to be used and must be experienced in the diagnosis and treatment of adverse
effects, systemic toxicity or other complications (see “If you use more Mepivacaina
Recordati than you should”).
The anesthetic solution must be injected with caution in small doses after approximately 10 seconds
from a preliminary aspiration. Especially when infiltrating highly
vascularized areas, it is advisable to wait about two minutes before proceeding with the actual
regional nerve block. The medicine must be used with extreme caution in
subjects undergoing treatment with MAOI drugs or tricyclic antidepressants.
Any overdose of anesthetic must be avoided and never administer two maximum doses of the latter without an interval of at least 24 hours.
It is nevertheless necessary to use the lowest doses and concentrations that can allow
to obtain the desired effect.
Some local anesthesia techniques may be associated with severe adverse reactions,
regardless of the local anesthetic used, such as:

• Central nervous system block: can cause cardiovascular depression especially in the presence of hypovolemia. Epidural anesthesia should be used with caution in patients with reduced cardiovascular function;
• Retrobulbar injections: can, in very rare cases, reach the cerebral subarachnoid space causing temporary blindness, cardiovascular collapse, apnea, convulsions, etc. Such reactions must be diagnosed and treated immediately;
• Retro- and peribulbar injections of local anesthetics: involve a low risk of persistent muscle dysfunction at the ocular level. Primary causes include trauma and/or local toxic effects on muscles and/or nerves. The severity of such reactions to the tissues is correlated with the extent of the trauma, the concentration of local anesthetic and the duration of tissue exposure to the local anesthetic. As with all local anesthetics, it is therefore necessary to use the lowest doses and concentrations that can allow to obtain the desired effect. Vasoconstrictors can worsen reactions to the tissues and should only be used when indicated;
• Accidental intra-arterial injections in the cranial and cervical region can cause serious symptoms even at low doses;
• Mepivacaina Recordati is not recommended in labor and delivery because placental passage of mepivacaine is relatively high while neonatal metabolism is slow. This increases the potential toxicity to the fetus and newborn.

The anesthetic solution must be injected with caution in small doses after approximately 10 seconds
from a preliminary aspiration. Especially when infiltrating highly
vascularized areas, it is advisable to wait about 2 minutes before proceeding with the actual
loco-regional block.
The patient must be kept under close monitoring, immediately suspending
administration at the first sign of alarm (e.g. change in sensorium).

Mepivacaine must be used with caution in patients undergoing treatment with other local anesthetics

or substances structurally related to amid-type local anesthetics, such as certain antiarrhythmics like mexiletine, as the systemic toxic effects are additive. Caution is advised in patients treated with Class III antiarrhythmics (e.g. amiodarone) despite the absence of specific interaction studies with this class of medicinal products. Absolute caution must be exercised in subjects undergoing treatment with MAO inhibitors or tricyclic antidepressants. In patients with advanced liver disease (Class C of the Child-Pugh classification), data from lidocaine suggest that clearance may be reduced by approximately 50%. A clinically relevant reduction in mepivacaine clearance is expected only in patients with severe renal insufficiency (CL (cr) <30 ml / min) who are not undergoing hemodialysis. A decrease in clearance is not expected to have an impact in the event of toxicity caused by high plasma concentrations after single doses for surgical anesthesia. However, in chronic renal insufficiency, the clearance of the PPX metabolite excreted via the kidneys is compromised and accumulation may occur after repeated administrations.

Immediate availability of equipment, medicines and qualified personnel for emergency treatment is necessary, as serious reactions, sometimes with fatal outcomes, have been reported following the use of local anesthetics, even in the absence of individual hypersensitivity in the medical history.Epidural anesthesia can cause hypotension and bradycardia. The risk can be reduced by pre-filling the circulation with crystalloid or colloid solutions. Hypotension should be treated immediately with administration, possibly repeated, of a sympathomimetic such as ephedrine 5-10 mg intravenously.

How to use Mepivacaine Recordati
The maximum doses in a healthy adult (not pre-treated with sedatives) in a single administration or in multiple administrations repeated within less than 90 minutes, of 7 mg/kg, never exceeding 550 mg. The total dose in 24 hours should never exceed 1000 mg; in pediatrics do not exceed 5-6 mg/kg. Do not use in pediatrics for dental and stomatologicalprocedures. When a prolonged block is used, for example through repeated administrations, the risk of reaching toxic plasma concentrations and inducing local neural injury must be assessed. In order to avoid intravascular administration, it is necessary to aspirate repeatedly before and during the administration of the main dose which must be injected slowly or in increasing doses, carefully observing the patient's vital functions and maintaining verbal contact. Accidental intravascular administration can be recognized by a temporary increase in heart rate, while accidental intrathecal administration can be recognized by signs of spinal block.

If signs of toxicity should occur, the injection must be immediately stopped.
Recommended doses:

Surgery
Peridural and caudal block: up to 400 mg achievable with 15-30 ml of a 10 mg/ml solution with 10-20 ml of a 20 mg/ml solution.

Paravertebral block: up to 400 mg with a 10 mg/ml solution for stellate ganglion block and for vegetative blocks, 10-20 mg/ml for paravertebral block of somatic nerves.

Cervical, brachial, intercostal, paracervical, pubic and nerve endings peripheral nerve block: up to 400 mg achievable with 5-20 ml of 10 mg/ml or 20 mg/ml solution depending on the area and extent of the block.

Infiltration: up to 400 mg depending on the area of the intervention, achievable with volumes ranging up to 40 ml of a 0.5-10 mg/ml solution.

Obstetrics
Paracervical block: up to 200 mg within a period of 90 minutes achievable with 10 ml of a 10 mg/ml solution on each side. Caution: vials, not containing preservative excipients, must be used for a single administration. Any remaining contents must be discarded.

Possible adverse effects
The profile of adverse reactions of Mepivacaine Recordati is similar to that of other amid-type local anesthetics. Drug adverse reactions are difficult to distinguish from the physiological effects resulting from nerve conduction block (such as decreased blood pressure, bradycardia) and events caused by the injection directly (e.g., nerve fiber trauma) or indirectly (e.g., epidural abscess).

Acute systemic toxicity
Systemic toxic reactions primarily involve the Central Nervous System (CNS) and the Cardiovascular System (CVS). These reactions are caused by a high blood concentration of local anesthetic which can be caused by accidental intravascular injection, overdose or exceptionally rapid absorption from a highly vascularized area (see “Warnings and precautions”). The reactions of the CNS are similar for all amid-type local anesthetics, while the cardiac reactions are more dependent on the medicinal product, both in quantitative and qualitative terms. Toxicity affecting the central nervous system often manifests gradually, with symptoms and signs of increasing severity. The first symptoms are usually a feeling of lightheadedness, paresthesia in the circumoral region, numbness of the tongue, tinnitus and visual disturbances. Dysarthria, muscle contractions and tremors are more serious manifestations and precede the onset of generalized seizures. These signs should not be confused with erotic behaviors. Unconsciousness and grand mal seizures may follow. After the convulsions, due to increased muscle activity, interference with normal breathing and failure of airway patency, hypoxia and hypercapnia develop rapidly. In severe cases, apnea may occur. Acidosis, hyperkalemia, hypocalcemia and hypoxia increase and extend the toxic effects of local anesthetics. The return of the patient to the initial clinical conditions is consequent to the redistribution of the local anesthetic from the central nervous system and the subsequent metabolism and excretion. Recovery can be rapid if large amounts of the drug have not been administered. In severe cases, effects on the cardiovascular systemmay occur which are generally preceded by signs of central nervous system toxicity. In patients undergoing general anesthesia or deeply sedated, the prodromal symptoms of the central nervous system may be absent. As a result of high systemic concentrations of local anesthetics, hypotension, bradycardia, arrhythmias and even cardiac arrest can occur. Cardiac arrest, in rare cases, has occurred without the appearance of prodromal effects of the central nervous system.

Treatment of acute systemic toxicity
Administration of the local anesthetic must be stopped immediately if signs of acute systemic toxicity appear and the symptoms of the CNS (seizures, CNS depression) must be rapidly treated with appropriate support of ventilation/respiration and with the administration of anticonvulsants. If circulatory arrest occurs, cardiopulmonary resuscitation must be performed immediately. It is vital to ensure optimal oxygenation, ventilation, support circulation and treat acidosis. In case of cardiovascular depression (hypotension, bradycardia) treatment with intravenous fluids, vasoconstrictors, chronotropes and/or inotropic agents should be considered. Doses administered to children must take into account age and weight. Oxygen should be administered and, if necessary, assisted ventilation (mask and Ambu bag or tracheal intubation) should be performed. If seizures do not stop spontaneously after 15-20 seconds, an anticonvulsant should be administered intravenously to facilitate adequate ventilation and oxygenation, for example, sodium thiopental 1-3 mg/kg intravenously. Alternatively, diazepam 0.1 mg/kg body weight can be administered intravenously, although its action is slow. Prolonged seizures can compromise ventilation and oxygenation of the patient. In such cases, the administration of a muscle relaxant (such as succinylcholine 1 mg/kg body weight) facilitates ventilation and control of oxygenation. In such situations, endotracheal intubation should be considered immediately. In case of evident cardiovascular depression (hypotension, bradycardia), a sympathomimetic, for example, ephedrine 5-10 mg, may be administered. Administration may be repeated, if necessary, after 2-3 minutes. The use of bulbous analeptics should be avoided to avoid worsening the situation by increasing oxygen consumption. Any seizures can be controlled with the use of diazepam in a dose of 10-20 mg intravenously; barbiturates are not recommended as they can accentuate bulbous depression. The circulation can be supported with the administration of corticosteroids in appropriate doses intravenously; diluted solutions of alpha-beta-stimulants with vasoconstrictor action (mefentermine, metaraminol and others) or atropine sulfate can be added. Sodium bicarbonate in targeted concentration can be used as an antiacidic agent, intravenously.