MEPIVACAINA 20 mg /Ml Roztwór Do Infuzji

Treść ulotki

1. MEPIVACAINA GUARDANT 20 mg/ml injectable solution
   1. What is Mepivacaina Guardant and what is it used for
   2. What you need to know before using Mepivacaina Guardant
   3. How Mepivacaina Guardant will be administered to you
   4. Possible Undesirable Effects
   5. How to store Mepivacaina Guardant
   6. Package contents and other information

MEPIVACAINA GUARDANT 20 mg/ml injectable solution

Mepivacaine hydrochloride

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 or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet:

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

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

Mepivacaina Guardant contains the active ingredient mepivacaine hydrochloride, a medicine belonging to the
group of local anesthetic drugs.
Mepivacaina Guardant is used to produce a loss of sensation (anesthetize) or a feeling
that is limited to a part of the body (local anesthesia) in adults and children.
Mepivacaina Guardant is used in surgical procedures (general surgery, obstetrics and
gynecology, urology, ophthalmology, dermatology, otorhinolaryngology and orthopedics) or for the elimination of
pain (e.g. neuralgia) in general medicine and in sports medicine (e.g. muscle tears).

2. What you need to know before using Mepivacaina Guardant

Do not use Mepivacaina Guardant:

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6); if you are allergic to other local anesthetics and/or similar substances;
• if you are pregnant or suspect you may be (see section Pregnancy and breastfeeding);
• if you have porphyria, an inherited disease that interferes with the production of red blood cells;
• if you suffer from heart rhythm disorders affecting the conduction of electrical current from the atrium to the ventricle (atrioventricular conduction);
• if you suffer from uncontrolled seizures;
• if you have had previous episodes of malignant hyperthermia (a life-threatening dangerous increase in body temperature);
• in children under 4 years of age;
• by intravenous route.

Warnings and precautions
Talk to your doctor or pharmacist before you are given Mepivacaina Guardant
Tell your doctor:

• if you are elderly or in poor general condition;
• if you suffer from heart disease, especially in case of shock, as local anesthetics can depress cardiac conduction;
• if you suffer from severe liver or kidney disease
• if you are taking class III antiarrhythmic drugs (e.g. amiodarone) to treat irregular heartbeat (see Other medicines and Mepivacaina Guardant). Your doctor may also subject you to an ECG monitoring (electrocardiogram, an examination to assess heart function);
• if you are taking medications for depression such as monoamine oxidase inhibitors (or MAOIs) or tricyclic antidepressants such as amitriptyline;
• in case of infection at the injection site;
• in case of epidural, subarachnoid or caudal anesthetics and especially if you suffer from neurological diseases, spinal deformities, sepsis or hypertension;

Children
In children, Mepivacaina Guardant is administered at appropriately reduced doses based on age and weight.
Mepivacaina Guardant should not be administered to children under 4 years of age (see section 2. Do not
use Mepivacaina Guardant).

Other medicines and Mepivacaina Guardant
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
In particular, tell your doctor if you are taking

• other local anesthetics or similar substances
• medicines such as mexiletine, or class III antiarrhythmics (e.g. amiodarone) used to treat heart rhythm disorders;
• medicines that are monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants), used to treat depression.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor for advice before you are given this medicine.

Pregnancy
Do not use Mepivacaina Guardant if you are pregnant or suspect you may be (see section 2. Do not use
Mepivacaina Guardant).
Mepivacaina Guardant is not recommended during labor and delivery.

Breastfeeding
Like other local anesthetics, mepivacaine hydrochloride can pass into breast milk.

Driving and using machines
Local anesthetics can have a very mild effect on mental function and coordination and
can temporarily negatively affect the ability to move and the degree of alertness.
Mepivacaina Guardant impairs the ability to drive vehicles and use machines.

Mepivacaina Guardant contains
This medicine contains 70.8mg of sodium (the main component of table salt) per bag. This
is equivalent to 3.5% of the recommended maximum daily intake with the diet of an adult.

3. How Mepivacaina Guardant will be administered to you

The dose will be established by the doctor based on your weight and your state of health.
Mepivacaina Guardant will be administered in the part of the body affected by a doctor specialized
in the use of this type of medicine, in adequately equipped facilities.
Mepivacaina Guardant must be administered as an injection.

Adult patients
The maximum dose in a healthy adult (not pre-treated with sedatives) in a single administration or in multiple
administrations repeated within less than 90 minutes is 7 mg/kg, never exceeding 550 mg.
The total dose in 24 hours must never exceed 1000 mg.

Elderly patients
No modification of the dose or frequency of administration is required.

Use in children
Mepivacaina Guardant should not be used in children under 4 years of age.
The dosage must be appropriately reduced in children (maximum dose 5-6 mg/kg).

If you are given more Mepivacaina Guardant than you should
It is very unlikely that you will be given more solution than necessary because your doctor will monitor you
during treatment.
Accidental injection of local anesthetics into a blood vessel can cause immediate generalized adverse effects
(from a few seconds to a few minutes). In case of overdose, the adverse effects manifest later (15-60 minutes after the injection (see section 4 Possible adverse effects).
Symptoms of drug overdose are characterized by:

• tremors, double vision (diplopia), uncontrolled body movements (convulsions) followed by depression, respiratory failure and coma;
• cardiovascular alterations with decreased blood pressure (hypotension) and decreased heart rate (bradycardia).

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4. Possible Undesirable Effects

Like all medicines, this medicine can cause undesirable effects, although not everybody gets them.
The possible undesirable effects after use of Mepivacaina Guardant largely correspond to those of other
local anesthetics. If, during the administration of Mepivacaina Guardant, you should experience the following serious
undesirable effects, the doctor will immediately stop administering the medicine and will
administer appropriate therapy:
excitement, tremors, disorientation, dizziness, dilation of the pupil (mydriasis), increased
metabolism and body temperature and, for very high doses, prolonged contraction of the jaw muscles
(trismus) and uncontrolled body movements (convulsions); sweating, heart rhythm disorders (arrhythmias), increased blood pressure (hypertension), increased respiratory rate
(tachypnea), increased diameter of the bronchi (bronchodilation), nausea and vomiting, decreased
heart rate (bradycardia) and increased diameter of blood vessels
(vasodilation), various types of skin rashes, urticaria, itching, bronchospasm, swelling of the larynx,
interruption of blood circulation and breathing (cardiorespiratory collapse) caused by a severe
allergic reaction (anaphylactic shock).
Below are listed the possible undesirable effects according to the following frequency:

Common (may affect up to 1 in 10 people)

• increased diameter of blood vessels (vasodilation)
• reduction, increased blood pressure (hypertension);
• nausea
• vomiting
• numbness (paresthesia), dizziness
• decreased heart rate (bradycardia)

Uncommon (may affect up to 1 in 100)
reduction of central nervous system activities (with convulsions; excitement;
numbness of the area around the mouth (paresthesia in the circumoral region);
insensitivity of the tongue; increased sensitivity to sounds (hyperacusis); visual disturbances; loss
of consciousness; drowsiness; tremor; prolonged contraction of the jaw muscles (trismus);
ringing in the ears (tinnitus); difficulty speaking (dysarthria); depression

• anxiety, disorientation

Rare (may affect up to 1 in 1000)

• nerve disease (neuropathy);
• nerve damage;
• inflammation of a meninges, the lining of the brain (arachnoiditis);
• allergic reactions such as various types of skin rashes, urticaria, itching, temporary
• narrowing of the bronchi that prevents air from passing into the lungs (bronchospasm);
• swelling of the larynx, the organ where the voice is created (laryngeal edema);
• increased respiratory rate (tachypnea), increased diameter of the bronchi that favors the passage of air into the lungs (bronchodilation);
• respiratory depression;
• double vision (diplopia), dilation of the pupil (mydriasis);
• heart problems up to cardiac arrest, arrhythmia,
• sweating
• increased metabolism and body temperature;

Reporting of Undesirable Effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store Mepivacaina Guardant

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 “Scad:”.
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
MEPIVACAINA GUARDANT must be used immediately after opening the bag and for a single
administration; after use, the container (and any remaining medicine) must be disposed of, even
if partially used.
Do not dispose of any medicine in wastewater 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 cloridrato contains

• The active ingredient is mepivacaine hydrochloride 20 mg.
• The other ingredients are:
• Sodium chloride,
• Water for injections,
• Sodium bicarbonate

Description of the appearance of Mepivacaina Guardant and package contents
Injectable solution.
Pack of 50 bags containing 20 ml of 20 mg/ml solution

MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Marketing Authorisation Holder
Guardant S.r.l. Via Pietro Campana, 4 – 00044 Frascati (RM)

MANUFACTURER
Infomed Fluids Srl Bdul Theodor Pallady, 50 – Sector 3, Bucharest- 032266- Romania

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The following information is intended exclusively for physicians or healthcare professionals:
The physician must have completed comprehensive and adequate training on the type of technique to be used and must be
experienced in the diagnosis and treatment of adverse effects, systemic toxicity or other complications. In
patients undergoing major block or receiving high doses of the drug, an intravenous catheter must be inserted, before
administration of the local anesthetic.
Before use, the physician must ascertain the physical condition of the subjects to be treated.
The anesthetic solution must be injected, after about 10 seconds of a first preventive aspiration,
slowly and with frequent aspirations. Especially when infiltrating highly vascularized areas, it is
advisable to wait about two minutes before proceeding with the actual loco-regional block.
Any overdose of anesthetic must be avoided and two maximum doses of the latter must never be administered without an interval of at least 24 hours having elapsed, for example when a
peripheral block fails for technical reasons.
It is good practice to use the lowest doses and concentrations that can allow to obtain the expected effect
and taking into account the age, weight and physical condition of the patient.
The administration of repeated doses can determine significant increases in plasma levels due to
accumulation of mepivacaine or its metabolites.
Drowsiness represents the first sign of elevated plasma levels which can also occur in cases of
rapid absorption or accidental intravenous injection.
Some local anesthesia techniques may be associated with severe adverse effects, such as:

• central nervous system block: can cause cardiovascular depression especially in the presence of hypovolemia;
• retro- and peribulbar 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. Furthermore, there is a 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 on the tissues is correlated with the extent of 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 exacerbate tissue reactions and should only be used when indicated.
• accidental intraarterial injections in the cranial and cervical region can cause severe symptoms even at low doses.
• 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.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
The maximum dose in healthy adults (not pre-treated with sedatives) in a single administration or in multiple
administrations within a time of less than 90 minutes, is 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.
The dosage should be appropriately reduced in children and critically ill patients (maximum dose 5-6 mg/kg).
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 (corresponding to 20 ml of solution).
• Paravertebral block: up to 400 mg (corresponding to 20 ml of solution) for paravertebral block of somatic nerves. N.B. For stellate ganglion block and for vegetative blocks, a 1% solution is recommended:therefore, Mepivacaina Guardant is not suitable.
• Cervical, brachial, intercostal, paracervical, pubic and nerve endings peripheral nerve block: up to 400 mg (corresponding to 20 ml of solution) depending on the area and extent of the block
• Intra-articular infiltration: up to 100 mg per joint to be anesthetized (corresponding to 5 ml of solution).
• Skin infiltration "as a barrier": up to 300 mg (corresponding to 15 ml of solution). Obstetrics
• Paracervical block: up to 200 mg (corresponding to 10 ml of solution) per side. Analgesic therapy
• Trigger point block in: up to 40 mg (corresponding to 2 ml of solution) per point and up to a maximum of 300 mg (corresponding to 15 ml of solution).

In the absence of specific compatibility information, MEPIVACAINA GUARDANT should not be
mixed with other substances.

Instructions for use of the bag
The bag of MEPIVACAINA GUARDANT provides two accesses (Fig. 1) that allow the withdrawal of the
solution according to two different modalities.
a) "needle tip" type connector which allows withdrawal with a syringe equipped with a needle (Fig. 2);
b) "male luer-lock" type connector, equipped with a manual rupture valve (Fig. 3), which allows
withdrawal using a needleless device (Fig. 4).

Fig. 1 Fig. 2 Fig. 3 Fig. 4