MEGANEST 40 mg/mL + 5 micrograms/mL Injectable Solution

2. What you need to know before you start using Meganest 40 mg/ml + 5 micrograms/ml injectable solution

Do not useMeganestif you have any of the following conditions:

• allergy to articaine, epinephrine, or any of the other components of this medication (listed in section 6).
• allergy to other local anesthetics.
• uncontrolled epilepsy.

Warnings and precautionsConsult your dentist before starting to use Meganestif you have any of the following conditions:

• severe heart rhythm disorders (e.g., second- and third-degree AV block).
• acute heart failure (sudden weakness of the heart, e.g., unexpected chest pain at rest or after a heart attack).
• low blood pressure.
• abnormally fast heartbeats.
• heart attack in the last 3-6 months.
• coronary revascularization graft in the last 3 months.
• you are taking medications for high blood pressure called beta-blockers, such as propranolol. There is a risk of hypertensive crisis (very high blood pressure) or severe slowing of the heart rate (see section "Use of Meganest injectable solution with other medications").
• very high blood pressure.
• you are taking medications for depression and Parkinson's disease (tricyclic antidepressants). These medications can enhance the effects of epinephrine.
• epilepsy.
• deficiency of a natural chemical called cholinesterase in the blood (plasma cholinesterase deficiency).
• kidney problems.
• severe liver problems.
• a disease called Myasthenia Gravis that causes muscle weakness.
• porphyria that causes neurological complications and skin problems.
• if you are using other local anesthetics that cause reversible loss of sensitivity (including volatile anesthetics, such as halothane).
• if you are taking medications called antiplatelet or anticoagulant to prevent narrowing or hardening of blood vessels in arms and legs.
• if you are over 70 years old.
• you have a history of heart problems.
• you have uncontrolled diabetes.
• a severe case of overactive thyroid (thyrotoxicosis).
• a tumor called pheochromocytoma.
• a disease called glaucoma that affects the eyes.
• inflammation or infection of the area where you will receive the injection.
• reduced oxygen levels in body tissues (hypoxia), high potassium levels in the blood (hyperkalemia), and metabolic disorders due to excessive acid in the blood (metabolic acidosis).

Use ofMeganestwith other medications

Tell your dentist if you are taking or have recently taken any other medication.

It is very important to inform your dentist if you are taking any of the following medications:

• Other local anesthetics that cause reversible loss of sensitivity (including volatile anesthetics, such as halothane).
• Sedatives (such as benzodiazepines, opioids), for example, to reduce anxiety before the dental procedure.
• Medications for heart and blood pressure (such as guanadrel, guanethidine, propranolol, nadolol).
• Tricyclic antidepressants for treating depression (such as amitriptyline, desipramine, imipramine, nortriptyline, maprotiline, and protriptyline).
• COMT inhibitors for treating Parkinson's disease (such as entacapone or tolcapone).
• MAO inhibitors for treating depressive or anxiety disorders (such as moclobemide, phenelzine, tranylcypromine, linezolid).
• Medications for treating irregular heartbeats (such as digitalis, quinidine).
• Medications for treating migraine attacks (such as methysergide or ergotamine).
• Sympathomimetic vasopressors (such as cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline), used to raise blood pressure: if taken in the 24 hours prior to the planned dental treatment, it should be postponed.
• Neuroleptic medications (such as phenothiazines).

Use ofMeganestwith food

Avoid eating, even chewing gum, until you have regained normal sensitivity. Otherwise, there is a risk of biting your lips, cheeks, or tongue, especially in children.

Pregnancy and breastfeedingand fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your dentist or doctor before using this medication.

Your dentist or doctor will decide if you can take Meganest 40 mg/ml + 5 micrograms/ml injectable solution or Meganest 40 mg/ml + 10 micrograms/ml injectable solution during pregnancy.

Breastfeeding can be resumed 5 hours after anesthesia.

No adverse effects on fertility are expected with the doses used in a dental procedure.

Driving and using machines

If you experience side effects, including dizziness, blurred vision, or fatigue, do not drive or operate machinery until you have regained your abilities (usually within 30 minutes after the dental procedure).

Meganest Articaine/Epinephrine 40 mg/ml + 5 micrograms/ml injectable solution and Meganest Articaine/Epinephrine 40 mg/ml + 10 micrograms/ml injectable solutioncontainsodium metabisulfiteand sodium.

This medication may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sodium metabisulfite.

This medication also contains less than 23 mg of sodium per dose, which is essentially "sodium-free".

Use in athletes

This medication contains articaine and epinephrine (adrenaline) that may produce a positive result in doping tests.

3. How to use Meganest 40 mg/ml + 5 micrograms/ml injectable solution

Only doctors and dentists are trained to use Meganest.

Your dentist will choose between Meganest 40 mg/ml + 5 micrograms/ml injectable solution or Meganest 40 mg/ml + 10 micrograms/ml injectable solution and determine the appropriate dose based on your age, weight, general health, and dental procedure.

The lowest dose that provides effective anesthesia should be used.

This medication is administered by slow injection into the oral cavity.

If you use moreMeganest 40 mg/ml + 5 micrograms/ml injectable solution or Meganest 40 mg/ml + 10 micrograms/ml injectable solutionthan you should

It is unlikely that you will be given too much of this injection, but if you start to feel unwell, tell your dentist. Symptoms of an overdose include acute weakness, pale skin, headache, agitation or restlessness, disorientation, loss of balance, tremors or involuntary twitching, dilated pupils, blurred vision, speech difficulties, dizziness, seizures, stupor, loss of consciousness, coma, yawning, abnormally slow or rapid breathing that can lead to temporary respiratory arrest, and heart failure.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you have any other questions about the use of this medication, ask your dentist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

When you are in the dentist's office, the dentist will closely monitor the effects of Meganest 40 mg/ml + 5 micrograms/ml injectable solution or Meganest 40 mg/ml + 10 micrograms/ml injectable solution.

• Tell your dentist, doctor, or pharmacistimmediatelyif you experience any of the following serious side effects:Swelling of the face, tongue, or pharynx, difficulty swallowing, hives, or difficulty breathing (angioedema).
• Rash, itching, swelling of the throat, and difficulty breathing: may be symptoms of an allergic reaction (hypersensitivity).
• A combination of drooping eyelid and constricted pupil (Horner's syndrome).

These side effects are rare (may affect up to 1 in 1,000 people).

In other patients, other side effects not listed above may also occur.

Common side effects: may affect up to 1 in 10 people:

• Gingivitis
• Neuropathic pain: pain due to nerve damage
• Numbness or decreased sensation in and around the mouth
• Metallic taste, altered taste, or loss of taste
• Increased sensation, unpleasant or abnormal sensation
• Increased sensitivity to heat
• Headache
• Abnormally fast heartbeats
• Abnormally slow heartbeats
• Low blood pressure
• Swelling of the tongue, lips, and gums.

Uncommon side effects: may affect up to 1 in 100 people:

• Burning sensation
• High blood pressure
• Inflammation of the tongue and mouth
• Nausea, vomiting, diarrhea
• Rash, itching
• Pain in the neck or at the injection site

Rare side effects: may affect up to 1 in 1,000 people:

• Nervousness, anxiety
• Facial nerve disorder (facial paralysis)
• Somnolence
• Involuntary eye movement
• Double vision, temporary blindness
• Drooping eyelid and constricted pupil (Horner's syndrome)
• Sinking of the eyeball into the orbit (enoftalmia)
• Ringing in the ears, increased sensitivity of the ear
• Palpitations
• Hot flashes
• Wheezing (bronchospasm, whistling), asthma
• Difficulty breathing
• Exfoliation and ulceration of the gums
• Exfoliation of the injection site
• Hives.
• Involuntary muscle contraction
• Fatigue, weakness
• Chills

Very rare side effects: may affect up to 1 in 10,000 people:

• Persistent loss of sensitivity, extensive numbness, and loss of taste

Frequency not known: cannot be estimated from available data:

• Extreme euphoria
• Heart conduction disorders (conduction disorders, atrioventricular block)
• Increased blood flow to a part of the body, leading to congestion of blood vessels
• Widening or narrowing of blood vessels
• Hoarseness
• Difficulty swallowing
• Swelling of the cheeks and local swelling
• Burning mouth syndrome
• Redness of the skin (erythema)
• Abnormal increase in sweating
• Worsening of neuromuscular symptoms of Kearns-Sayre syndrome
• Feeling of heat or cold
• Jaw locking

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet.

You can also report them directly through the Spanish Medicines Agency's online reporting system: www.notificaRAM.es By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Meganest 40 mg/ml + 5 micrograms/ml injectable solution

No special storage conditions are required.

Keep this medication out of sight and reach of children.

Do not use this medicationafter the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Do not use this medication if you notice that the solution is cloudy or has changed color.

The cartridges are for single use. Use immediately after opening the cartridge. Unused solution should be discarded.

Medications should not be disposed of through wastewater or household waste. Your dentist will know how to dispose of unused medications, which will help protect the environment.

6. Container Content and Additional Information

Meganest Composition40 mg/ml + 5 micrograms/ml injectable solution

• The active ingredients are articaína hydrochloride and adrenaline tartrate.

• Each 1.8 ml cartridge of Meganest40 mg/ml + 5 micrograms/ml injectable solution contains 72 mg of articaína hydrochloride and 9 micrograms of adrenaline (as adrenaline tartrate).
• Each milliliter of Meganest40 mg/ml + 5 micrograms/ml injectable solution contains 40 mg of articaína hydrochloride and 5 micrograms of adrenaline (as adrenaline tartrate).

• The other components (excipients) are: sodium metabisulfite, sodium chloride, sodium hydroxide or hydrochloric acid (for pH adjustment), water for injectable preparations.

Product Appearance and Container Content

Meganest40 mg/ml + 5 micrograms/ml injectable solution is a colorless and transparent injectable solution.

Container containing 50 cartridges of 1.8 ml.

Container containing 1 cartridge of 1.8 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Clarben S.A.

Av. Valdelaparra 27

28108 Alcobendas

Spain

Manufacturer

Laboratorios Clarben S.A.

C/ Eduardo Marconi, 2. Polígono Industrial Codein.

Fuenlabrada (Madrid)- 28946

Spain.

This leaflet was last revised inFebruary 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

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This information is intended only for healthcare professionals:

Dosage

For all populations, the lowest dose that provides effective anesthesia should be used. The necessary dose must be determined individually.

For a routine procedure, the normal dose for adult patients is 1 cartridge, but the content of less than one cartridge may be sufficient for effective anesthesia. According to the dentist's judgment, more cartridges may be required for more extensive procedures, without exceeding the recommended maximum dose.

In the case of most routine dental procedures, it is preferable to use Meganest40 mg/ml + 5 micrograms/ml injectable solution.

For more complex procedures, such as pronounced hemostasis, it is preferable to use Meganest40 mg/ml + 10 micrograms/ml injectable solution.

Concomitant use of sedatives to reduce patient anxiety:

The maximum safe dose of the local anesthetic may be reduced in sedated patients due to an additive effect on central nervous system depression.

Adults and adolescents (between 12 and 18 years old)In adults and adolescents, the maximum dose of articaína is 7 mg/kg, with an absolute maximum dose of articaína of 500 mg. The maximum dose of articaína of 500 mg corresponds to a healthy adult weighing over 70 kg.

Children (between 4 and 11 years old)

The safety of Meganest40 mg/ml + 5 micrograms/ml injectable solution has not been established in children under 4 years of age. No data are available.

The amount to be injected must be determined based on the child's age and weight and the magnitude of the operation. The effective average dose is 2 mg/kg and 4 mg/kg for simple and complex procedures, respectively. The lowest dose that provides effective dental anesthesia should be used. In children from 4 years old (or from 20 kg (44 lbs) of body weight) and older, the maximum dose of articaína is only 7 mg/kg, with an absolute maximum dose of 385 mg of articaína for a healthy child weighing 55 kg.

Special populations

Elderly patients and patients with renal disorders:

Due to the lack of clinical data, special precautions should be taken to administer the lowest dose that provides effective anesthesia in elderly patients and in patients with renal disorders.

High plasma levels of the medication may occur in these patients, especially after repeated use. In case of re-injection, the patient should be closely monitored to identify any signs of relative overdose.

Patient with hepatic insufficiency

For patients with hepatic insufficiency, special precautions should be taken to administer the lowest dose that provides effective anesthesia, especially after repeated use, although 90% of articaína is first inactivated by non-specific plasma esterases of tissues and blood.

Patient with plasma cholinesterase deficiency

High plasma levels of the medication may occur in patients with cholinesterase deficiency or under treatment with acetylcholinesterase inhibitors, since the product is inactivated by 90% by plasma esterases. Therefore, the lowest dose that provides effective anesthesia should be used.

Administration Method

Infiltration and perineural use in the oral cavity.

If there is inflammation and/or infection at the injection site, local anesthesia should be injected with caution. The injection speed should be very slow (1 ml/min).

Precautions to be taken before handling or administering the medication

This medication should only be used by a doctor or a dentist with sufficient training and familiar with the diagnosis and treatment of systemic toxicity, or under their supervision. Before inducing regional anesthesia with local anesthetics, the availability of a resuscitation team and adequate medication should be ensured to provide immediate treatment for any respiratory or cardiovascular emergency. The patient's level of consciousness should be monitored after each injection of local anesthesia.

When using Meganest40 mg/ml + 5 micrograms/ml injectable solution for infiltration or regional anesthetic block, the injection should always be administered slowly and with prior aspiration.

Special Warnings

Adrenaline reduces blood flow to the gums, which can cause local tissue necrosis.

Very rare cases of prolonged or irreversible nerve damage and taste loss have been reported after mandibular block anesthesia.

Precautions for Use

Risk associated with accidental intravascular injection:

An accidental intravascular injection can cause high levels of adrenaline and articaína in the systemic circulation. This can be associated with serious adverse reactions, such as convulsions, followed by central nervous system depression and cardiorespiratory arrest, which progresses to respiratory and circulatory arrest.

Therefore, to ensure that the needle does not penetrate a blood vessel during injection, aspiration should be performed before injecting the local anesthetic. However, the absence of blood in the syringe does not guarantee that intravascular injection has not occurred.Risk associated with intraneural injection:

An accidental intraneural injection can cause the drug to move retrogradely through the nerve.

To avoid intraneural injection and prevent nerve damage when performing nerve blocks, the needle should be slightly withdrawn whenever the patient feels a sensation of discharge during injection or if the injection is particularly painful. If nerve damage occurs due to the needle, the neurotoxic effect may be worsened by the possible neurotoxicity of articaína and the presence of adrenaline, as it can reduce perineural blood flow and prevent local elimination of articaína.

Overdose Treatment

Before administering regional anesthesia with local anesthetics, the availability of a resuscitation team and adequate medication should be ensured to provide immediate treatment for any respiratory or cardiovascular emergency.

Depending on the severity of the overdose symptoms, the doctor or dentist should implement protocols that anticipate the need to protect the airways and provide assisted ventilation.

The patient's level of consciousness should be monitored after each injection of local anesthesia.

If signs of acute systemic toxicity appear, the injection of the local anesthetic should be stopped immediately. If necessary, the patient should be placed in a supine position.

The symptoms of the CNS (convulsions, CNS depression) should be treated immediately with adequate respiratory support and the administration of anticonvulsant medications.

Optimal oxygenation and ventilation, along with circulatory support and treatment of acidosis, can prevent cardiac arrest. If cardiovascular depression (hypotension, bradycardia) occurs, adequate treatment with intravenous fluids, vasopressors, or inotropic agents should be considered. Children should be administered doses according to their age and weight.

In case of cardiac arrest, cardiopulmonary resuscitation should be performed immediately.

Special Precautions for Elimination and Other Handling

This medication should not be used if the solution is turbid or has changed color.

To avoid the risk of infection (e.g., transmission of hepatitis), the syringe and needles used to prepare the solution should always be new and sterile.

The cartridges are for single use. If only part of the cartridge is used, the rest should be discarded.

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

This information is intended only for healthcare professionals

Local injection / Dental use. For exclusive use in dental anesthesia.

To avoid intravascular injection, aspiration control should always be performed in at least two planes (needle rotation of 180º), although a negative aspiration result does not rule out involuntary and unnoticed intravascular injection.

The injection speed should not exceed 0.5 ml in 15 seconds, i.e., 1 cartridge/minute.

Major systemic reactions, resulting from accidental intravascular injection, can be avoided in most cases by a technical injection (after aspiration, slow injection of 0.1-0.2 ml and slow application of the rest, not before 20-30 seconds have passed).

Accidental injection may be associated with convulsions followed by central nervous system or cardiorespiratory arrest. Resuscitation equipment, oxygen, and other resuscitation medications should be available for immediate use.

Opened cartridges should not be used in other patients. Residues should be discarded.

The technical data sheet includes guidelines and recommendations to ensure correct use of the product (see Dosage and Administration; Warnings and Special Precautions for Use)