ARTICAINA 40 mg /Ml + 10 Mikrogramów/Ml Roztwór Do Wstrzykiwań

Treść ulotki

1. ARTICAINA OGNA
   1. What is ARTICAINA OGNA and what is it used for?
   2. What you need to know before using ARTICAINA OGNA
   3. How to use ARTICAINA OGNA
   4. Possible side effects
   5. How to store ARTICAINA OGNA
   6. Package contents and other information

ARTICAINA OGNA

40 mg/ml + 5 micrograms/ml, injectable solution with adrenaline
40 mg/ml + 10 micrograms/ml, injectable solution with adrenaline
Articaine hydrochloride/adrenaline

Read this leaflet carefully before you are given 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 dentist, doctor or pharmacist.
• If you get any side effects, see section 4, and speak to your dentist, doctor or pharmacist.

Contents of this leaflet:

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

1. What is ARTICAINA OGNA and what is it used for?

ARTICAINA OGNA is used to numb (anaesthetize) the oral cavity during dental procedures.
This medicine contains two active ingredients:

• Articaine, a local anesthetic that prevents pain;
• Adrenaline, a vasoconstrictor that constricts blood vessels at the injection site, thereby prolonging the effect of articaine. Furthermore, adrenaline reduces bleeding during surgical intervention.

ARTICAINA OGNA will be administered by a dentist.
ARTICAINA OGNA is indicated for children over 4 years of age (approximately 20 kg body weight),
adolescents and adults.
Based on the type of dental procedure to be performed, the dentist will choose one of the two medicines:

• ARTICAINA OGNA 40 mg/ml + 5 micrograms/ml, injectable solution with adrenaline is generally used for simple and short dental procedures,
• ARTICAINA OGNA 40 mg/ml + 10 micrograms/ml, injectable solution with adrenaline is more suitable for longer procedures or those that may involve significant bleeding.

2. What you need to know before using ARTICAINA OGNA

You will not be given ARTICAINA OGNA if you suffer from any of the following conditions:

• allergy to articaine or adrenaline or to any of the other components of this medicine (listed in section 6);
• allergy to other local anesthetics;
• epilepsy that is not adequately controlled with drug treatment. Warnings and precautionsConsult your dentist before you are given ARTICAINA OGNA if you suffer from any of the following conditions:
• severe heart rhythm disorders (e.g. second and third degree atrioventricular block);
• acute heart failure (acute weakness of the heart muscle, e.g. sudden chest pain at rest or after a myocardial infarction (e.g. heart attack));
• low blood pressure;
• abnormally rapid heart rate;
• heart attack in the last 3-6 months;
• coronary artery bypass surgery in the last 3 months;
• taking medicines for blood pressure called beta-blockers, such as propranolol. There is a risk of a hypertensive crisis (very high blood pressure) or a severe slowing of the heart rate (see section Other medicines);
• very high blood pressure;
• taking medicines at the same time for the treatment of depression and Parkinson's disease (tricyclic antidepressants). These medicines can intensify the effects of adrenaline;
• epilepsy;
• deficiency of a natural chemical called cholinesterase in the blood (cholinesterase deficiency in plasma);
• kidney problems;
• severe liver problems;
• a disease called myasthenia gravis, which causes muscle weakness;
• porphyria, which causes neurological complications or skin problems;
• use of other local anesthetics, medicines that cause a reversible loss of sensation (including volatile anesthetics such as halothane);
• taking medicines, called antiplatelet agents or anticoagulants, to prevent the narrowing or hardening of blood vessels in the arms and legs;
• age over 70 years;
• any current or past heart problems;
• uncontrolled diabetes;
• excessive thyroid activity (thyrotoxicosis);
• a tumor called pheochromocytoma;
• a disease called closed-angle glaucoma that affects the eyes;
• inflammation or infection in the area where the injection is to be given;
• reduced amounts of oxygen in body tissues (hypoxia), high levels of potassium in the blood (hyperkalemia) and metabolic disorders resulting from an excess of acid in the blood (metabolic acidosis).

Other medicines and ARTICAINA OGNA
Tell your dentist if you are taking, have recently taken or might take any other medicines.
It is particularly important to tell your dentist if you are taking any of the following medicines:

• other local anesthetics, medicines that cause a reversible loss of sensation (including volatile anesthetics such as halothane);
• sedatives (e.g. benzodiazepines, opioids), for example to reduce anxiety before dental procedures;
• medicines for the heart and blood pressure (e.g. guanadrel, guanethidine, propranolol, nadolol);
• tricyclic antidepressants used for the treatment of depression (e.g. amitriptyline, desipramine, imipramine, nortriptyline, maprotiline and protriptyline);
• COMT inhibitors used for the treatment of Parkinson's disease (e.g. entacapone or tolcapone);
• MAO inhibitors used for the treatment of depressive or anxiety disorders (e.g. moclobemide, phenelzine, tranylcypromine, linezolid);
• medicines used for the treatment of irregular heartbeats (e.g. digoxin, quinidine);
• medicines used for migraine attacks (e.g. methysergide or ergotamine);
• sympathomimetic vasopressors (e.g. cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline) used to increase blood pressure: if used within the previous 24 hours, the scheduled dental treatment should be postponed;
• neuroleptic drugs (e.g. phenothiazines).

ARTICAINA OGNA with food
Avoid eating or chewing gum until normal sensation returns, as there is a
risk of biting your lips, cheeks or tongue, especially in children.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy or are breastfeeding with breast
milk, ask your dentist or doctor for advice before you are given this medicine.
Your dentist or doctor will decide whether you can take ARTICAINA OGNA during pregnancy.
Breastfeeding can be resumed 5 hours after anesthesia.
No adverse effects on fertility are expected at the doses used for dental procedures.

Driving and operating machinery
If you experience side effects such as dizziness, blurred vision or fatigue, you should not drive or
operate machinery until your abilities are fully restored (usually within 30 minutes of the dental procedure).

ARTICAINA OGNA contains sodium and sodium metabisulfite

• Sodium: less than 23 mg per cartridge; this means that it is practically ‘sodium-free’.
• Sodium metabisulfite: rarely may cause serious allergic reactions and breathing difficulties (bronchospasm). If there is a risk of an allergic reaction, your dentist will choose a different medicine for anesthesia.

3. How to use ARTICAINA OGNA

Only doctors and dentists are competent in the use of ARTICAINA OGNA.
The dentist will choose whether to use 40 mg/ml + 5 micrograms/ml, injectable solution with adrenaline or 40 mg/ml
+ 10 micrograms/ml, injectable solution with adrenaline and will determine the appropriate dose in
consideration of their age, weight, general health condition and the dental procedure.
The lowest effective dose capable of inducing anesthesia must be used.
This medicine is administered by slow injection into the oral cavity.

If you are given more ARTICAINA OGNA than you should
It is unlikely that you will be given an excessive amount of injection; however, if you should begin to
feel unwell, inform your dentist. Symptoms of overdose include severe weakness, paleness
of the skin, headache, agitation or restlessness, disorientation, loss of balance, involuntary tremor
or chills, dilation of the pupils, blurred vision, problems focusing on objects,
speech disorders, dizziness, convulsions, stupor, loss of consciousness, coma, yawning, abnormal
breathing slowed or accelerated which can cause temporary cessation of breathing, inability of the heart to
contract effectively (cardiac arrest).
If you have any doubts about the use of this medicine, consult your dentist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During your stay at the dental practice, the dentist will carefully monitor the effects of
ARTICAINA OGNA.

Immediately inform your dentist, doctor or pharmacist if you experience any of the following serious side effects:

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

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

• inflammation of the gums
• neuropathic pain: pain due to nerve damage
• numbness or decreased sensation inside and around the mouth
• metallic taste, altered or loss of taste
• increased, unpleasant or abnormal tactile sensitivity
• increased sensitivity to heat
• headache
• abnormally increased heart rate
• abnormally decreased heart rate
• 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, diarrhoea
• skin 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 disorders (facial paralysis)
• drowsiness
• involuntary eye movements
• double vision, temporary blindness
• drooping eyelid and constricted pupil (Horner's syndrome)
• dislocation with recession of the eyeball within the orbit due to changes in orbital volume (enophthalmos)
• ringing in the ears, hypersensitivity to hearing
• palpitations
• hot flushes
• wheezing (bronchospasm), asthma
• difficulty breathing
• exfoliation and ulceration of the gums
• exfoliation at the injection site
• hives
• muscle spasms, involuntary muscle contraction
• fatigue, weakness
• chills

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

• persistent loss of sensation, widespread numbness and loss of taste

Not known: (frequency cannot be estimated from available data)

• excessive good mood (euphoria)
• problems with heart rate coordination (conduction disturbances, atrioventricular block)
• increased amount of blood in a part of the body, resulting in congestion of blood vessels
• dilation or constriction of blood vessels
• hoarseness
• difficulty swallowing
• swelling of the cheeks and localized
• burning mouth syndrome
• redness of the skin (erythema)
• abnormally increased sweating
• worsening of neuromuscular symptoms in Kearns-Sayre syndrome
• feeling of warmth or cold
• jaw locking

Reporting of side effects
If you get any side effects, talk to your dentist, 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.
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store ARTICAINA OGNA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Store at a temperature below 25 °C.
Do not freeze.
Store the cartridges in the outer packaging, tightly closed, to protect the medicine from light.
Do not use this medicine if you notice that the solution is cloudy or changes colour.
The cartridges are for single use. Use immediately after opening the cartridge. Discard any
unused solution.
Do not dispose of any medicine in wastewater or household waste. Ask your dentist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ARTICAINA OGNA contains
The active ingredients are articaine hydrochloride and adrenaline tartrate.

• Each 1.8 ml cartridge of ARTICAINA OGNA 40 mg/ml + 5 micrograms/ml, injectable solution with adrenaline contains 72 mg of articaine hydrochloride and 9 micrograms of adrenaline (as adrenaline tartrate).
• 1 ml of ARTICAINA OGNA 40 mg/ml + 5 micrograms/ml, injectable solution with adrenaline contains 40 mg articaine hydrochloride and 5 micrograms of adrenaline (as adrenaline tartrate).
• Each 1.8/ml cartridge of ARTICAINA OGNA 40 mg/ml + 10 micrograms/ml, injectable solution with adrenaline contains 72 mg of articaine hydrochloride and 18 micrograms of adrenaline (as adrenaline tartrate).
• 1 ml of ARTICAINA OGNA 40 mg/ml + 10 micrograms/ml, injectable solution with adrenaline contains 40 mg articaine hydrochloride and 10 micrograms of adrenaline (as adrenaline tartrate).

The other ingredients are sodium chloride, sodium metabisulfite (E223), water for
injections.

Description of the appearance of ARTICAINA OGNA and contents of the pack
ARTICAINA OGNA is a clear and colorless solution.
It is packaged in single-use glass cartridges sealed at the base with a movable rubber plunger and at the
top with a rubber seal locked by an aluminum cap.
Box containing 50 glass cartridges of 1.8 ml.

Marketing authorization holder
GIOVANNI OGNA & Figli S.r.l.
Via Figini, 41 – 20835 Muggiò (MB)

Manufacturer
Pierrel S.p.A.
Strada Statale Appia , 46/48 – 81043 Capua (CE)

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The following information is intended exclusively for doctors or healthcare professionals
Dosage and administration
For all populations, the lowest effective dose capable of inducing anesthesia should be used. The
necessary dosage must be determined on an individual basis.
For a routine procedure, the normal dose for adult patients is 1 cartridge, but the content of less than
one cartridge may be sufficient to achieve effective anesthesia. At the dentist's discretion, more than one
cartridge may be necessary for more complex procedures, without exceeding the recommended maximum
dose.
For most routine dental procedures, it is preferable to use ARTICAINA OGNA 40 mg/ml + 5
micrograms/ml, injectable solution with adrenaline .
For more complex procedures, for example those requiring pronounced hemostasis, it is preferable
to use ARTICAINA OGNA 40 mg/ml + 10 micrograms/ml, injectable solution with adrenaline .
Concomitant use of sedatives to reduce patient anxiety:
The safe maximum dose of local anesthetic may be reduced in sedated patients due to the additive
effect of central nervous system depression.

Adults and adolescents (ages 12 to 18)
In adults and adolescents, the maximum dose of articaine is 7 mg/kg, with an absolute maximum dose of
500 mg. The maximum dose of 500 mg of articaine refers to a healthy adult with a body weight greater than
70 kg.

Children (ages 4 to 11)
The safety of ARTICAINA OGNA in children under 4 years of age has not been established. No data are
available.
The amount to be injected must be established based on the child's age and weight, as well as the extent
of the intervention. The average effective dose is 2 mg/kg and 4 mg/kg respectively for simple and
complex procedures. The lowest effective dose capable of inducing anesthesia should be used. In children 4 years
of age (or at least 20 kg (44 pounds) of body weight) and older, the maximum dose of articaine is only 7
mg/kg, with an absolute maximum dose of 385 mg of articaine for a healthy child weighing 55 kg
body weight.

Special populations

Elderly patients and patients with renal impairment
Due to the lack of clinical data, special precautions must be taken to administer the lowest effective dose
capable of inducing anesthesia in elderly patients and those with renal impairment.
Elevated plasma levels of the product may occur in these patients, especially after repeated use. If repeat
injection is necessary, the patient should be carefully monitored to identify any signs of relative overdose.

Patients with hepatic impairment
Special precautions must be taken to administer the lowest effective dose capable of
inducing anesthesia in patients with hepatic impairment, particularly after repeated use, although the
90% of articaine is inactivated by nonspecific plasma esterases in the tissues and in the blood.

Patients with plasma cholinesterase deficiency
Elevated plasma levels of the product may occur in patients with cholinesterase deficiency or undergoing
treatment with acetylcholinesterase inhibitors, as the product is 90% inactivated by plasma esterases.
Therefore, the lowest effective dose capable of inducing anesthesia should be used.

Route of administration
Infiltration and perineural use in the oral cavity.
Local anesthetics should be injected with caution in the presence of inflammation and/or infection at the
injection site. The injection should be performed very slowly (1 ml/min).
Precautions to be taken before handling or administering the medicine
This medicine should only be used by doctors or dentists with adequate knowledge and
experience in the diagnosis and treatment of systemic toxicity or under their supervision. Before
inducing regional anesthesia with local anesthetics, it is necessary to ensure the availability of appropriate
equipment and drugs for resuscitation, to ensure the immediate treatment of any respiratory and
cardiovascular emergencies. The patient's state of consciousness must be monitored after each injection
of local anesthetic.
When using ARTICAINA OGNA for anesthesia by infiltration or loco-regional block, the injection
must always be performed slowly and after aspiration.

Special warnings
Adrenaline reduces blood flow in the gums, which can cause local tissue necrosis.
Very rare cases of nerve injury and prolonged or irreversible loss of taste have been reported following
analgesia of the mandibular block.

Precautions for use

Risks associated with accidental intravascular injection
Accidental intravascular injection can cause a sudden increase in adrenaline and
articaine levels in the systemic circulation. This may be associated with serious adverse reactions, such as
seizures, followed by cardiorespiratory and central nervous system depression and coma, evolving into
respiratory and circulatory arrest.
Therefore, to ensure that the needle does not penetrate a blood vessel during injection, it is necessary to aspirate
before injecting the local anesthetic medicine. However, the absence of blood in the syringe does not guarantee
that intravascular injection has been avoided.

Risks associated with intraneural injection
Accidental intraneural injection can cause the drug to rise along the nerve.
To avoid intraneural injection and prevent nerve injury related to nerve blocks, the needle should
be retracted slightly if the patient feels a sensation of electric shock during injection
or if the injection is particularly painful. In case of nerve injury, the neurotoxic effect may be
aggravated by the potential chemical neurotoxicity of articaine and the presence of adrenaline, as this
can reduce perineural blood supply and prevent the elimination of articaine locally.

Overdose treatment
Before administering regional anesthesia with local anesthetics, it is necessary to ensure the availability
of equipment and drugs for resuscitation, to ensure the immediate treatment of any
respiratory and cardiovascular emergencies.
The severity of the symptoms of overdose should prompt the doctor/dentist to implement protocols that
provide for the need to promptly protect the airways and practice assisted ventilation.
The patient's state of consciousness must be monitored after each injection of local anesthetic.
If signs of acute systemic toxicity occur, the injection of the local anesthetic must be
immediately stopped. If necessary, place the patient in a supine position.
Symptoms of the CNS (seizures, CNS depression) should be treated immediately with
appropriate respiratory/airway support and the administration of anticonvulsant drugs.
Optimal oxygenation, ventilation and circulatory support, together with the treatment
of acidosis, can prevent cardiac arrest.
In case of cardiovascular depression (hypotension, bradycardia), it is appropriate to consider the opportunity
to carry out appropriate treatment with intravenous fluids, vasopressors and/or inotropes. In children, the
dose administered must be adjusted to age and weight.
In case of cardiac arrest, cardiopulmonary resuscitation must be started immediately.

Special precautions for disposal and handling
This medicine should not be used if the solution is cloudy or changes color.
To avoid the risk of infection (e.g. transmission of hepatitis), the syringes and needles used to
draw the solution must always be new and sterile.
The cartridges are for single use. If a vial is partially used, discard the remaining solution.
Unused medicine and waste derived from such medicine must be disposed of in accordance with
local regulations.