Septanest z adrenalinom 1:100 000

PATIENT INFORMATION LEAFLET

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

SEPTANEST WITH ADRENALINE 1:200,000 (40 MG + 0.005MG) /ML,

injection solution

SEPTANEST WITH ADRENALINE 1:100,000 (40 MG + 0.01MG) /ML, INJECTION SOLUTION

articaine hydrochloride + adrenaline
You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a dentist, doctor, or pharmacist.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform the dentist, doctor, or pharmacist. See section 4.

TABLE OF CONTENTS OF THE LEAFLET

• 1. What Septanest with adrenaline is and what it is used for
• 2. Important information before using Septanest with adrenaline
• 3. How to use Septanest with adrenaline
• 4. Possible side effects
• 5. How to store Septanest with adrenaline
• 6. Contents of the package and other information

1. WHAT SEPTANEST WITH ADRENALINE IS AND WHAT IT IS USED FOR

Septanest with adrenaline is used to numb the mouth during dental procedures.
This medicine contains two active substances:

• articaine, a local anesthetic that prevents pain and
• adrenaline, a vasoconstrictor that narrows blood vessels at the injection site, thereby prolonging the effect of articaine. It also reduces bleeding during the procedure.

Septanest with adrenaline 1:200,000 (40 mg+0.005mg) /ml or Septanest with adrenaline 1:100,000 (40 mg + 0.01mg) /ml is administered to the patient by a dentist.
Septanest with adrenaline is intended for children over 4 years old (approximately 20 kg body weight), adolescents, and adults.
Depending on the type of dental procedure, the dentist will decide which of the two medicines to use:

• Septanest with adrenaline 1:200,000 (40 mg + 0.005mg) /ml is usually used for simple and short dental procedures
• Septanest with adrenaline 1:100,000 (40 mg + 0.01mg) /ml is more suitable for procedures that take longer or are associated with potentially greater bleeding.

2. IMPORTANT INFORMATION BEFORE USING SEPTANEST WITH ADRENALINE

WHEN NOT TO USE SEPTANEST WITH ADRENALINE, IF THE PATIENT HAS ANY OF THE FOLLOWING DISEASES:

• the patient is allergic to articaine or adrenaline or any of the other ingredients of this medicine (listed in section 6);
• the patient is allergic to other local anesthetics;
• the patient has uncontrolled epilepsy.

WARNINGS AND PRECAUTIONS

Before starting to use Septanest with adrenaline, the patient should discuss with their dentist if they have any of the following conditions:

• severe heart rhythm disorders (e.g., atrioventricular block of degree II and III);
• acute heart failure (acute weakening of the heart, e.g., unexpected chest pain at rest or after a heart attack (i.e., myocardial infarction));
• low blood pressure;
• abnormally fast heart rate;
• heart attack in the last 3-6 months;
• the patient underwent aortocoronary bypass surgery in the last 3 months;
• the patient is taking blood pressure-lowering medications called beta-adrenergic blockers, such as propranolol. There is a risk of hypertensive crisis (very high blood pressure) or severe slowing of heart rate (see section Septanest with adrenaline and other medicines);
• very high blood pressure;
• the patient is taking certain medications used to treat depression and Parkinson's disease (tricyclic antidepressants). These medications enhance the effect of adrenaline;
• epilepsy;
• the patient's blood lacks a natural chemical called cholinesterase (cholinesterase deficiency);
• kidney problems;
• severe liver disease;
• a disease called myasthenia gravis, which causes muscle weakness;
• porphyria, which causes neurological complications or skin problems;
• the patient is using other local anesthetics, medications that cause temporary loss of sensation (including inhalation anesthetics, such as halothane);
• the patient is taking antiplatelet or anticoagulant medications to prevent narrowing or hardening of blood vessels in the arms and legs;
• the patient is over 70 years old;
• the patient has had or currently has heart disease;
• uncontrolled diabetes;
• severe hyperthyroidism (thyrotoxicosis);
• a tumor called pheochromocytoma;
• a disease called closed-angle glaucoma, which is an eye disease;
• inflammation or infection at the injection site;
• decreased oxygen levels in body tissues (hypoxia), high potassium levels (hyperkalemia), and metabolic disorders due to excessive levels of acidic components in the blood (metabolic acidosis).

SEPTANEST WITH ADRENALINE AND OTHER MEDICINES

The patient should tell their dentist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
It is especially important to inform the dentist if the patient is taking any of the following medications:

• other local anesthetics, medications that cause reversible loss of sensation (including inhalation anesthetics, such as halothane);
• sedatives (such as benzodiazepines, opioids), for example, to reduce anxiety before a dental procedure;
• medications that affect the heart and lower blood pressure (such as guanadrel, guanethidine, propranolol, nadolol);
• tricyclic antidepressants used to treat depression (such as amitriptyline, desipramine, imipramine, nortriptyline, maprotiline, and protriptyline);
• COMT inhibitors used to treat Parkinson's disease (such as entacapone or tolcapone);
• MAO inhibitors used to treat depressive or anxiety disorders (such as moclobemide, phenelzine, tranylcypromine, linezolid);
• medications used to treat irregular heartbeat (such as digitalis, quinidine);
• medications used to treat migraine attacks (such as methysergide or ergotamine);
• sympathomimetic medications that constrict blood vessels (such as cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline) used to increase blood pressure: if they have been used in the last 24 hours, the planned dental treatment should be postponed;
• neuroleptic medications (such as phenothiazines).

SEPTANEST WITH ADRENALINE AND FOOD

The patient should avoid eating, including chewing gum, until normal sensation returns, due to the risk of biting their lip, cheek, or tongue, especially in children.

PREGNANCY, BREASTFEEDING, AND FERTILITY

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their dentist or doctor before using this medicine.
The dentist or doctor will decide whether the patient can use Septanest with adrenaline during pregnancy.
Breastfeeding can be resumed 5 hours after anesthesia administration.
No effect on fertility is expected after doses used in dental procedures.

DRIVING AND USING MACHINES

In case of side effects, including dizziness, blurred vision, or fatigue, the patient should not drive or operate machinery until they feel normal again (usually within 30 minutes after the dental procedure).

SEPTANEST WITH ADRENALINE CONTAINS SODIUM AND SODIUM METABISULFITE.

• Sodium: less than 23 mg of sodium per cartridge, which means the medicine is considered "sodium-free".
• Sodium metabisulfite: in rare cases, it can cause severe allergic reactions and respiratory disorders (bronchospasm). If there is a risk of an allergic reaction, the dentist will choose a different anesthetic.

3. HOW TO USE SEPTANEST WITH ADRENALINE

Only doctors or dentists with proper training should use Septanest with adrenaline.
The dentist will decide whether to use Septanest with adrenaline 1:200,000 or Septanest with adrenaline 1:100,000 and will determine the appropriate dose, taking into account the patient's age, body weight, and overall health, as well as the dental procedure.
The smallest dose that allows for effective anesthesia should be used.
This medicine is administered by slow injection into the mouth.

USING A HIGHER DOSE OF SEPTANEST WITH ADRENALINE THAN RECOMMENDED

It is unlikely that the patient will receive too much of this medicine, but if they feel unwell, they should tell their dentist. Overdose symptoms include severe weakness, pallor, headache, feeling of excitement or overexcitement, feeling of disorientation, loss of balance, involuntary twitching or convulsions, pupil dilation, blurred vision, speech disorders, dizziness, convulsions, stupor, loss of consciousness, sleepiness, yawning, abnormal breathing, which can lead to temporary cessation of breathing, and ineffective heart contractions (cardiac arrest).
In case of any further doubts related to the use of the medicine, the patient should consult their dentist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Septanest with adrenaline can cause side effects, although not everybody gets them.
During the patient's stay in the dentist's office, the patient will be closely monitored by the dentist for the effects of Septanest with adrenaline.
The patient should immediately inform the dentist, doctor, or pharmacist if they experience any of the following serious side effects:

• facial swelling, tongue or throat swelling, swallowing difficulties, hives, or breathing difficulties (angioedema)
• rash, itching, throat swelling, and breathing difficulties: these may be symptoms of an allergic reaction (hypersensitivity)
• drooping eyelid and pupil constriction (Horner's syndrome) These side effects may occur rarely (may affect up to 1 in 1,000 patients). Other side effects not listed above may also occur in some patients.

COMMON SIDE EFFECTS: MAY OCCUR IN UP TO 1 IN 10 PATIENTS:

• gum inflammation
• neuropathic pain - caused by nerve damage
• tingling or numbness in the mouth and around the mouth
• metallic taste, taste disturbances, or loss of taste
• increased, unpleasant, or abnormal sensation of touch
• increased sensitivity to heat
• headache
• abnormally fast heart rate
• abnormally slow heart rate
• low blood pressure
• tongue, lip, and gum swelling

UNCOMMON SIDE EFFECTS: MAY OCCUR IN UP TO 1 IN 100 PATIENTS:

• burning sensation
• high blood pressure
• tongue and mouth inflammation
• nausea, vomiting, diarrhea
• rash, sweating
• neck or injection site pain

RARE SIDE EFFECTS: MAY OCCUR IN UP TO 1 IN 1,000 PATIENTS:

• nervousness, anxiety
• facial nerve disorders (facial nerve palsy)
• drowsiness
• involuntary eye movements
• double vision, temporary blindness
• drooping eyelid and pupil constriction (Horner's syndrome)
• displacement of the eyeball into the orbit (enoftalmia)
• ringing in the ears, increased hearing sensitivity
• palpitations
• hot flashes
• wheezing, asthma
• breathing difficulties
• scaling and ulceration of the gums
• scaling at the injection site
• hives
• minor muscle spasms, involuntary muscle spasms
• weakness, fatigue
• chills.

VERY RARE SIDE EFFECTS: MAY OCCUR IN UP TO 1 IN 10,000 PATIENTS:

• permanent loss of sensation, prolonged numbness, or loss of taste

FREQUENCY NOT KNOWN: FREQUENCY CANNOT BE ESTIMATED FROM THE AVAILABLE DATA

• extremely good mood (euphoria)
• heart rhythm disorders (conduction disorders, atrioventricular block)
• increased blood flow to a part of the body, leading to congestion in blood vessels
• vessel dilation or constriction
• hoarseness
• swallowing difficulties
• cheek and local swelling
• burning mouth syndrome
• skin redness (flushing)
• abnormal sweating
• exacerbation of neuromuscular symptoms of Kearns-Sayre syndrome
• feeling of heat or cold
• tingling sensation.

REPORTING SIDE EFFECTS

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their dentist, doctor, or pharmacist.
Side effects can be reported directly to:
Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw,
Phone: +48 22 49 21 301
Fax: +48 22 40 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps to gather more information on the safety of medicines.

5. HOW TO STORE SEPTANEST WITH ADRENALINE

The medicine should be stored in a place inaccessible to children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of the stated month.
The abbreviation "Lot" means batch number.
Store at a temperature below 30°C.
Do not freeze.
Cartridges should be stored in the outer packaging to protect them from light.
Do not use this medicine if the solution is cloudy or discolored.
Cartridges are for single use. They should be used immediately after opening.
Any unused solution should be discarded.
Medicines should not be disposed of via wastewater or household waste. The dentist knows how to dispose of unused medicines. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

WHAT SEPTANEST WITH ADRENALINE CONTAINS

• The active substances of the medicine are articaine hydrochloride and adrenaline tartrate. Each cartridge with 1.7 ml of Septanest with adrenaline 1:200,000 (40 mg + 0.005mg)/ml injection solution contains 68 mg of articaine hydrochloride and 8.5 micrograms of adrenaline (as adrenaline tartrate). 1 ml of Septanest with adrenaline 1:200,000 (40 mg + 0.005mg) contains 40 mg of articaine hydrochloride and 5 micrograms of adrenaline (as adrenaline tartrate). Each cartridge with 1.7 ml of Septanest with adrenaline 1:100,000 (40 mg + 0.01mg)/ml injection solution contains 68 mg of articaine hydrochloride and 17 micrograms of adrenaline (as adrenaline tartrate). 1 ml of Septanest with adrenaline 1:100,000 (40 mg + 0.01mg) contains 40 mg of articaine hydrochloride and 10 micrograms of adrenaline (as adrenaline tartrate).
• The other ingredients are sodium chloride, sodium metabisulfite (E223), sodium hydroxide, and water for injections.

WHAT SEPTANEST WITH ADRENALINE LOOKS LIKE AND CONTENTS OF THE PACKAGE

Septanest with adrenaline is a clear and colorless solution.
It is packaged in single-dose glass cartridges, sealed with a movable rubber stopper at the bottom and a rubber plug at the top, held by an aluminum cap.
The carton contains 50 x 1.7 ml glass cartridges.
The carton contains 50 x 1.7 ml glass cartridges with auto-aspiration.
The package contains 4 cartons with 50 x 1.7 ml glass cartridges.
The package contains 8 cartons with 50 x 1.7 ml glass cartridges.
Not all pack sizes may be marketed.

MARKETING AUTHORIZATION HOLDER AND MANUFACTURER

SEPTODONT
58, rue du Pont de Créteil
94100 Saint Maur des Fossés
France

THIS MEDICINE IS AUTHORIZED IN THE MEMBER STATES OF THE EUROPEAN ECONOMIC AREA UNDER THE FOLLOWING NAMES:

Austria:
Septanest mit Epinephrin 1:200.000 40 mg/ml + 5 Mikrogramm/ml, Injektionslösung
Septanest mit Epinephrin 1:100.000 40 mg/ml + 10 Mikrogramm/ml, Injektionslösung
Belgium:
Septanest Normal 40 mg/mL+ 5 microgrammes/mL, solution injectable
Septanest Special, 40 mg/mL+ 10 microgrammes/mL, solution injectable
Bulgaria:
Септанест 1/200 000, 40 mg/ml+5 микрограма /ml инжекционен разтвор
Септанест 1/100 000, 40 mg/ml+10 микрограма /ml инжекционен разтвор
Croatia:
Septanest 40 mg/ml + 0,005 mg/ml otopina za injekciju
Septanest Forte 40 mg/ml + 0,01 mg/ml otopina za injekciju
Cyprus:
Septanest, 40 mg/ml + 5 micrograms/ml, ενέσιμο διάλυμα
Septanest Forte, 40 mg/ml + 10 micrograms/ml, ενέσιμο διάλυμα
Czech Republic:
Septanest s adrenalinem 1:200 000, 40 mg/ml + 5 mikrogramů/ml, injekční roztok
Septanest s adrenalinem 1:100 000, 40 mg/ml + 10 mikrogramů/ml, injekční roztok
Denmark:
Septanest, 40 mg/ml + 5 mikrogram/ml, injektionsvæske, opløsning
Septocaine, 40 mg/ml + 10 mikrogram/ml, injektionsvæske, opløsning
Estonia:
Septanest, 40 mg/ml + 5 mikrogrammi/ml, süstelahus
Septanest Forte, 40 mg/ml + 10 mikrogrammi/ml, süstelahus
Finland:
Septocaine, 40 mg/ml + 5 mikrogrammaa/ml, injektioneste, liuos
Septocaine Forte, 40 mg/ml + 10 mikrogrammaa/ml, injektioneste, liuos
France:
Septanest 40 mg/mL Adrénalinée au 1/200 000, solution injectable à usage dentaire
Septanest 40 mg/mL Adrénalinée au 1/100 000, solution injectable à usage dentaire
Germany:
Septanest mit Epinephrin 1:200.000 - 40 mg/ml + 0,005 mg/ml, Injektionslösung
Septanest mit Epinephrin 1:100.000 - 40 mg/ml + 0,01 mg/ml, Injektionslösung
Greece:
Septanest Articaine 4% υδροχλωριούχο με επινεφρίνη 1/200000 Οδοντικές αμπούλες Ενέσιμη λύση
Septanest Articaine 4% υδροχλωριούχο με επινεφρίνη 1/100000 Οδοντικές αμπούλες Ενέσιμη λύση
Hungary:
Septanest 40 mg/ml + 10 mikrogramm/ml, injekciós oldat
Italy:
Septanest 40 mg/ml + 5 microgrammi/ml soluzione iniettabile con adrenalina
Septanest 40 mg/ml + 10 microgrammi/ml soluzione iniettabile con adrenalina
Latvia:
Septanest 40 mg/ml + 5 mikrogrami/ml šķīdums injekcijām
Septanest Forte 40 mg/ml + 10 mikrogrami/ml šķīdums injekcijām
Lithuania:
Septanest 40 mg/ml + 5 mikrogramai/ml, injekcinis tirpalas
Septanest Forte 40 mg/ml + 10 mikrogramai/ml, injekcinis tirpalas
Luxembourg:
Septanest Normal, 40 mg/ml+ 5 microgrammes/ml, solution injectable
Septanest Spécial, 40 mg/ml+ 10 microgrammes/ml, solution injectable
Malta:
Septanest with adrenaline 1/200,000, 40 mg/ml + 5 mikrogrammi/ml, soluzzjoni għall-injezzjoni
Septanest with adrenaline 1/100,000, 40 mg/ml + 10 mikrogrammi/ml, soluzzjoni għall-injezzjoni
Netherlands:
Septanest N 40 mg/ml + 5 microgram/ml, oplossing voor injectie
Septanest SP 40 mg/ml + 10 microgram/ml, oplossing voor injectie
Norway:
Septocaine 40 mg/ml+5 mikrog/ml, injeksjonsvæske, oppløsning
Septocaine Forte 40 mg/ml+10 mikrog/ml, injeksjonsvæske, oppløsning
Poland:
SEPTANEST WITH ADRENALINE 1:200,000 (40 MG+0.005MG) /ML, INJECTION SOLUTION
SEPTANEST WITH ADRENALINE 1:100,000 (40 MG+0.01MG) /ML, INJECTION SOLUTION
Portugal:
Septanest 1/200,000, 40 mg/ml + 5 microgramas/ml, solução injetável
Septanest 1/100,000, 40 mg/ml + 10 microgramas/ml, solução injetável
Romania:
SEPTANEST CU ADRENALINĂ 1/200000 40 mg/0,005 mg/ml soluție injectabilă
SEPTANEST CU ADRENALINĂ 1/100000 40 mg/0,01 mg/ml soluție injectabilă
Slovakia:
Septanest 40 mg/ml + 5 mikrogramov/ml injekčný roztok
Septanest Forte 40 mg/ml + 10 mikrogramov/ml injekčný roztok
Slovenia:
Septanestepi 40 mg/0,005 mg v 1 ml raztopina za injiciranje
Septanestepi 40 mg/0,01 mg v 1 ml raztopina za injiciranje
Spain:
Septanest con adrenalina 40 mg/ml + 5 microgramos/ml solución inyectable
Septanest con adrenalina 40 mg/ml + 10 microgramos/ml solución inyectable
Sweden:
Septocaine 40 mg/ml + 5 mikrogram/ml, injektionsvätska, lösning
Septocaine Forte 40 mg/ml + 10 mikrogram/ml, injektionsvätska, lösning

DATE OF LAST REVISION OF THE LEAFLET: 05/2022

OTHER SOURCES OF INFORMATION

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products (http://www.urpl.gov.pl/pl).
Information intended exclusively for healthcare professionals:

DOSAGE

In all populations, the smallest dose that allows for effective anesthesia should be used. The required dose should be determined individually.
For routine procedures in adults, usually one cartridge is used, but less than the contents of one cartridge may be sufficient to achieve effective anesthesia. During more extensive procedures, it may be necessary to administer more cartridges, without exceeding the maximum recommended dose; the decision is made by the dentist.
For most routine dental procedures, Septanest with adrenaline 1:200,000 (40 mg + 0.005mg) /ml is preferred. In more complex dental procedures, such as those requiring intensive hemostasis, Septanest with adrenaline 1:100,000 (40 mg + 0.01mg) /ml is preferred.
Concomitant use of sedatives to reduce patient anxiety:
In patients who have been given a sedative, the maximum safe dose of local anesthetic may be reduced due to the additive effect of these medications causing central nervous system depression.
Children and adolescents (aged 12-18 years)
In adults and adolescents, the maximum dose of articaine is 7 mg/kg body weight, but the dose of articaine should not exceed 500 mg. The maximum dose of articaine 500 mg corresponds to a dose for a healthy adult with a body weight of over 70 kg.
Children (aged 4-11 years)
The safety of Septanest with adrenaline in children under 4 years of age has not been established. There are no available data.
The amount of medicine to be injected should be determined based on the child's age and body weight, as well as the scope of the procedure. The effective dose of articaine is 2 mg/kg body weight and 4 mg/kg body weight for simple and complex procedures, respectively. The smallest dose that allows for effective dental anesthesia should be used. In children over 4 years old (or over 20 kg body weight), the maximum dose of articaine is 7 mg/kg body weight, but the dose of articaine should not exceed 385 mg in a healthy child with a body weight of 55 kg.
Special patient groups
Elderly patients and patients with kidney disorders:
Due to the lack of clinical data, special caution should be exercised when administering the smallest dose that allows for effective anesthesia in elderly patients and patients with kidney disorders.
In the serum of these patients, increased levels of the product may occur, especially after repeated administration. If it is necessary to repeat the injection of the medicinal product, the patient should be closely monitored to recognize any signs of relative overdose.
Patients with liver function disorders: Special caution should be exercised when administering the smallest dose that allows for effective anesthesia in patients with liver function disorders, especially after repeated administration, although 90% of articaine undergoes first-pass inactivation by non-specific esterases in tissues and blood.
Patients with cholinesterase deficiency: In patients with cholinesterase deficiency or those undergoing treatment with acetylcholinesterase inhibitors, increased levels of the product may occur in the serum, as the product is inactivated by 90% by serum esterases. Therefore, the smallest dose that allows for effective anesthesia should be used.

ADMINISTRATION METHOD

Intramuscular injection and perineural injection in the mouth.
Local anesthetics should be injected cautiously in the presence of inflammation and (or) infection at the injection site. The rate of injection should be very slow (1 ml/min).
Precautions to be taken before using or administering the medicinal product:
This medicinal product should only be used by doctors or dentists with sufficient training and familiarization with the recognition and treatment of systemic toxic effects and with the equipment for resuscitation and emergency treatment of cardiovascular and respiratory systems. Before inducing local anesthesia with a local anesthetic, it should be ensured that appropriate resuscitation equipment and medications are available to treat any emergency situations related to the cardiovascular and respiratory systems. After each injection of a local anesthetic, the patient's level of consciousness should be monitored.
When using Septanest with adrenaline for nasal or conductive anesthesia, the injection should always be performed slowly and with prior aspiration.

SPECIAL WARNINGS

Adrenaline disrupts blood flow in the gums, which can lead to local tissue necrosis.
After conductive anesthesia, very rare cases of prolonged or irreversible nerve damage and taste loss have been reported.

PRECAUTIONS FOR USE

Risks associated with accidental intravascular injection:
Accidental intravascular injection can cause sudden high levels of adrenaline and articaine in the systemic circulation. This can be associated with severe side effects, such as seizures, followed by central nervous system depression and cardiovascular and respiratory system depression, and sleepiness, leading to respiratory and cardiac arrest.
To ensure that the needle does not penetrate a blood vessel during injection, aspiration should be performed before administering the medicinal product with local anesthetic effect. However, the absence of blood in the syringe does not guarantee that the injection will not be administered into a blood vessel.
Risks associated with injection into a nerve:
Accidental injection into a nerve can cause the medicine to spread backward along the nerve.
To avoid injecting into a nerve and to prevent nerve damage associated with its blockade, the needle should always be carefully withdrawn if the patient experiences a sensation similar to an electric shock during insertion or if the insertion is particularly painful. If nerve damage occurs, the neurotoxic effect may be enhanced due to the potential neurotoxicity of articaine and the presence of adrenaline, as it may delay the peri-neural blood flow and prevent the local washing out of articaine.

TREATMENT OF OVERDOSAGE

Before inducing local anesthesia with a local anesthetic, it should be ensured that resuscitation equipment and medications are available to treat any emergency situations related to the cardiovascular and respiratory systems.
The severity of overdose symptoms should prompt doctors/dentists to implement protocols that provide for the timely securing of airways and ensuring respiratory support.
After each injection of a local anesthetic, the patient's level of consciousness should be monitored.
In case of acute systemic toxic effects, the injection of the local anesthetic should be discontinued immediately. If necessary, the patient's position should be changed to a supine position.
Symptoms from the central nervous system (seizures, central nervous system depression) should be treated immediately with appropriate airway management and respiratory support, as well as the administration of anticonvulsant medications.
Ensuring optimal oxygen supply and supporting respiration and circulation, as well as treating acidosis, may prevent cardiac arrest.
In case of cardiovascular system depression (hypotension, bradycardia), the use of appropriate treatment with intravenous fluids, vasoconstrictors, and (or) inotropic agents should be considered. Children should be given doses appropriate for their age and body weight.
In case of cardiac arrest, cardiopulmonary resuscitation should be started immediately.

SPECIAL PRECAUTIONS FOR DISPOSAL AND PREPARATION OF THE MEDICINAL PRODUCT FOR ADMINISTRATION

Do not use this medicinal product if the solution is cloudy or discolored.
To avoid the risk of infection (e.g., transmission of hepatitis), the syringes and needles used to draw up the solution must always be new and sterile.
Cartridges are for single use. If only part of the contents has been used, the remainder should be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.