PACKAGE LEAFLET

MEPIVACAINA CON ADRENALINA PIERREL

20 mg/ml injectable solution with adrenaline 1:100,000, 100 cartridges of 1.8 ml
Composition
Mepivacaine 20 mg/ml injectable solution with adrenaline 1:100,000
Each ml of solution contains:
Active Substance:
Mepivacaine HCl 20.00 mg
Adrenaline bitartrate 18.20 mcg
equivalent to 10 mcg of adrenaline
Excipients:
Sodium metabisulfite, sodium chloride, water for injections.
Pharmaceutical form and pack sizes
Injectible solution.
The injectable solution is available in the following pack sizes:
Carton containing 100 cartridges of 1.8 ml of mepivacaine 20 mg/ml solution with adrenaline 1:100,000.
Pharmacotherapeutic category
Local injectable anaesthetic for exclusive dental use.
Marketing Authorisation Holder and Manufacturer
Pierrel S.p.A.
Strada Statale Appia 7 bis, 46/48 – 81043 Capua (CE)
Name of the manufacturer
Pierrel S.p.A.
Strada Statale Appia 7 bis, n. 46/48 – 81043 Capua (CE)
Indications
Local and regional nerve block anaesthesia for stomatological and dental use.
Mepivacaine with Adrenaline is particularly indicated when absolute ischaemia in the anaesthetized area for a prolonged period is desired, thus allowing longer and more delicate procedures.
Contraindications
Known hypersensitivity to the components.
It is contraindicated in cases of known intolerance to other local anaesthetics of the same chemical group.
Administration of mepivacaine is contraindicated in cases of: severe myasthenia gravis, low plasma cholinesterase levels, severe hepatic insufficiency.
For mepivacaine 20 mg/ml injectable solution with adrenaline 1:100,000, as with all local anaesthetics containing adrenaline, intravenous administration is contraindicated.
Classic contraindications for adrenaline when used as a vasoconstrictor in combination with local anaesthetics are: cardiac diseases, severe arteriopathies, hypertension, ischemic manifestations of any type, essential migraine, nephropathies, hyperthyroidism, diabetes and narrow-angle glaucoma.
Do not use in case of confirmed or suspected pregnancy.
Appropriate usage precautions
Before use, the physician must verify the patient's general health status and circulatory conditions; must also inquire about ongoing therapies and any previous allergic reactions. Any overdose of anaesthetic must be avoided, and two maximum doses must never be administered without an interval of at least 24 hours. In any case, the lowest effective doses and concentrations should be used. The anaesthetic solution must be injected cautiously in small amounts, approximately 10 seconds after a preliminary aspiration. Especially when infiltrating highly vascularized areas, it is advisable to wait approximately 2 minutes before proceeding with the actual loco-regional block. The patient must be kept under close monitoring, and administration must be stopped immediately at the first sign of alarm (e.g. changes in consciousness).
Warning
It is essential to have immediate access to emergency equipment, drugs, and trained personnel, since rare but severe reactions, sometimes with fatal outcomes, have been reported following the use of local anaesthetics, even in the absence of individual hypersensitivity in the patient's history.
Local anaesthesia should be avoided in infected areas and inflamed tissues.
Interactions
No severe interactions with other drugs are known; however, due to the presence of a sympathomimetic vasoconstrictor such as adrenaline, the drug must be used with extreme caution in patients undergoing treatment with MAO inhibitors or tricyclic antidepressants.
Special warnings
Warning: Mepivacaine 20 mg/ml injectable solution with adrenaline 1:100,000 contains sodium metabisulfite as a preservative: this substance may cause allergic-type reactions and severe asthma attacks, particularly in sensitive individuals and especially in asthmatics.
Direct intravenous administration must be absolutely avoided.
To prevent biting of lips, tongue and mucous membranes, the patient must be advised not to chew anything until sensitivity has returned.
Do not use in case of confirmed or suspected pregnancy.
Dosage, method and route of administration
Adults
1 or 3 cartridges of 1.8 ml per procedure, depending on the extent of the area to be anaesthetized and the injection technique used.
Disinfect the cartridge diaphragm before use with 70% ethyl alcohol or 90% pharmaceutical-grade isopropyl alcohol.
Cartridges must not be immersed in any type of solution.
It is advisable not to repeat administration more than once a week in the same patient.
Based on the above and considering the active substance concentration per cartridge, the maximum amount that may be administered in a single session should be calculated as follows:
Mepivacaine 20 mg/ml with adrenaline injectable solution 1:100,000, maximum dosage for administration of 3 cartridges of 1.8 ml.
Mepivacaine HCl: 3 x 36.00 mg = 108.00 mg
Adrenaline (1:100,000): 3 x 0.018 mg = 0.054 mg, equivalent to 1.8 mg/kg of anaesthetic and 0.0009 mg/kg of adrenaline, based on a 60 kg patient.
Under no circumstances should the dose of mepivacaine exceed 300 mg per session.
Children
Dosage will be determined according to age, extent of the procedure, and taking into account the child's weight.
The maximum recommended dose is 0.025 ml of anaesthetic solution per kg of body weight. The total dose must not exceed one cartridge per session.
The maximum dose of mepivacaine HCl that can be administered to a child, expressed in mg, can be calculated as follows: child's weight (kg) x 1.33.
Overdose
At the first sign of alarm, administration must be stopped, the patient placed in a horizontal position, and airway patency ensured, administering oxygen in case of severe dyspnoea or performing artificial ventilation (Ambu bag). The use of analeptics should be avoided, as they may worsen the situation by increasing oxygen consumption. Any seizures may be controlled with diazepam 10–20 mg intravenously; barbiturates are not recommended as they may exacerbate bulbar depression. Circulation may be supported by intravenous administration of appropriate doses of corticosteroids; diluted solutions of alpha- and beta-stimulants with vasoconstrictor action (methoxamine, metaraminol, and others) or atropine sulfate may be added. Sodium bicarbonate, in targeted concentration, may be used intravenously as an antiacid.
Undesirable effects
Undesirable effects may arise from high plasma levels and hypersensitivity reactions, attributable to both the anaesthetic and the vasoconstrictor.
Effects due to the anaesthetic:
Undesirable effects due to high plasma levels affecting both the CNS and the cardiovascular system have been described. CNS effects include: excitation, tremors, disorientation, dizziness, mydriasis, increased metabolism and body temperature, and, at very high doses, trismus and convulsions. If the medulla oblongata is involved, cardiovascular, respiratory and emetic centres may be affected, resulting in sweating, arrhythmias, hypertension, tachypnoea, bronchodilation, nausea and vomiting. Peripheral cardiovascular effects include bradycardia and vasodilation.
Allergic reactions mostly occur in hypersensitive subjects, but many cases have been reported even in the absence of known individual hypersensitivity in the patient's history. Local manifestations include various types of skin eruptions, urticaria, pruritus; general manifestations include bronchospasm, laryngeal oedema, and cardiorespiratory collapse due to anaphylactic shock.
Effects due to the vasoconstrictor:
Due to its action on circulation, it may cause various undesirable effects, especially in patients with pre-existing cardiovascular conditions: anxiety, sweating, respiratory difficulty, cardiac arrhythmias, hypertension (particularly severe in already hypertensive patients and hyperthyroid individuals), acute headache, photophobia, retrosternal and pharyngeal pain, vomiting; if such symptoms occur, administration must be stopped immediately.
If any other adverse effects related to the use of this medicine occur, inform your doctor.
Expiry
See expiry date on outer packaging.
Do not store above 25°C.
The date refers to the product in intact packaging, correctly stored.
Warning: do not use the product after this date.
KEEP OUT OF SIGHT AND REACH OF CHILDREN