КАРТИДОНТ 40 MG/ML + 10 MICROGRAMMI/ML Injectable solution

Содержание инструкции

1. Cartidont 40 mg/ml + 5 micrograms /ml, injectable solution with adrenaline, 40 mg/ml + 10 micrograms/ml, injectable solution with adrenaline
   1. What is CARTIDONT and what is it used for
   2. What you need to know before using CARTIDONT
   3. How to use CARTIDONT
   4. How to store CARTIDONT
   5. Contents of the pack and other information

Cartidont 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 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 dentist, doctor or pharmacist.
• If any side effects occur, including those not listed in this leaflet, ask your dentist, doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is CARTIDONT and what is it used for

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

• articaine, a local anaesthetic that prevents pain, and
• adrenaline, a vasoconstrictor that constricts blood vessels at the injection site, thus prolonging the effect of articaine. Furthermore, adrenaline reduces bleeding during surgical intervention.

CARTIDONT will be administered to you by a dentist.
CARTIDONT is indicated for children over 4 years of age (approximately 20 kg of body
weight), adolescents and adults.
Depending on the type of dental procedure to be performed, the dentist will choose one of the two
medicines:
CARTIDONT 40mg/ml + 5 micrograms/ml injectable solution with adrenaline is
generally used for short-duration dental procedures,
CARTIDONT 40mg/ml + 10 micrograms/ml injectable solution with adrenaline is more
suitable for longer-lasting procedures or those that may involve significant bleeding.

2. What you need to know before using CARTIDONT

Do not use CARTIDONT if you suffer from any of the following conditions:

• allergy to articaine or adrenaline, or to any of the other ingredients of this medicine (listed in section 6);
• allergy to other local anesthetics;
• epilepsy that is not adequately controlled with pharmacological treatment.

Warnings and precautions
Consult your dentist before using CARTIDONT if you suffer from any of the
following:

• severe heart rhythm disturbances (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 for the treatment of depression and Parkinson's disease (tricyclic antidepressants) at the same time. 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 and 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 narrowing or hardening of the blood vessels in the arms and legs;
• age over 70 years;
• any current or past heart problems;
• uncontrolled diabetes;
• excessive thyroid activity (hyperthyroidism);
• 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 (hyperpotassemia) and metabolic disorders resulting from an excess of acid in the blood (metabolic acidosis).

Other medicines and CARTIDONT
Tell your dentist if you are taking, have recently taken or might take
any other medicine.
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 to treat depression (e.g. amitriptyline, desipramine, imipramine, nortriptyline, maprotiline and protriptyline);
• COMT inhibitors used to treat Parkinson's disease (e.g. entacapone or tolcapone);
• MAO inhibitors used to treat depressive or anxiety disorders (e.g. moclobemide, phenelzine, tranylcypromine, linezolid);
• medicines used to treat irregular heartbeats (e.g. digoxin, quinidine);
• medicines used for migraine attacks (e.g. metisergide or ergotamine);
• sympathomimetic vasopressors (e.g. cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline) used to increase blood pressure: if used within the 24 hours prior, the scheduled dental treatment should be postponed;
• neuroleptic drugs (e.g. phenothiazines)

.

CARTIDONT 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 are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your dentist or doctor for advice before using this
medicine.
Your dentist or doctor will decide whether you can take CARTIDONT 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,
do not drive or operate machinery until your abilities are fully recovered
(usually within 30 minutes of the dental procedure).

CARTIDONT 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).

3. How to use CARTIDONT

Only doctors and dentists are competent in the use of CARTIDONT.
The dentist will choose whether to use CARTIDONT 40 mg/ml + 5 micrograms/ml or
CARTIDONT 40 mg/ml + 10 micrograms/ml 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 CARTIDONT 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 the dentist. Symptoms of
overdosage include severe weakness, pallor of the skin, headache, agitation
or restlessness, disorientation, loss of balance, involuntary tremor or chills,
pupil dilation, blurred vision, problems focusing objects,
speech disorders, dizziness, convulsions, stupor, loss of consciousness, coma,
yawning, abnormal slowed or accelerated breathing which may cause a 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 the dentist.

• 4. Possible side effectsLike all medicines, this medicine can cause side effects, although not everyone will experience them.

During your stay in the dental practice, the dentist will carefully monitor the
effects of CARTIDONT.

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

• swelling of the face, tongue or pharynx, difficulty swallowing, urticaria 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 constriction of the pupil (Horner's syndrome).

These side effects occur rarely (may affect up to 1 in 1,000 people). Other side effects not included in the above list 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 sensitivity 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, diarrhea
• 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
• difficulty breathing
• wheezing (bronchospasm), asthma
• palpitations
• involuntary eye movements
• double vision, temporary blindness
• drooping eyelid and constriction of the 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 of hearing
• hot flashes
• exfoliation and ulceration of the gums
• exfoliation at the injection site
• urticaria
• muscle spasms, involuntary muscle contraction
• fatigue, weakness
• chills

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

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

Not known: (frequency cannot be estimated based on 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)
• increased abnormal sweating
• worsening of neuromuscular symptoms in Kearns-Sayre syndrome
• feeling of warmth or cold
• jaw locking

Reporting of side effects
If you experience any side effects, including those not listed in this
leaflet, please inform 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 .
By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store CARTIDONT

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
pack after “Exp.”. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C. Do not freeze. Store in the
original packaging 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 medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CARTIDONT contains

• The active ingredients are articaine hydrochloride adrenaline tartrate. o Each 1.7 ml cartridge of CARTIDONT 40 mg/ml + 5 micrograms/ml injectable solution with adrenaline contains 68 mg of articaine hydrochloride and 8.5 micrograms of adrenaline (as adrenaline tartrate). o 1 ml of CARTIDONT 40 mg/ml + 5 micrograms/ml injectable solution with adrenaline contains 40 mg articaine hydrochloride and 5 micrograms of adrenaline (as adrenaline tartrate)

Each 1.7 ml cartridge of CARTIDONT 40 mg/ml + 10
micrograms/ml injectable solution with adrenaline contains 68 mg of articaine
hydrochloride and 17 micrograms of adrenaline (as adrenaline tartrate).
1 ml of CARTIDONT 40 mg/ml + 10 micrograms/ml injectable solution with adrenaline
contains 40 mg of articaine hydrochloride and 10 µg of adrenaline (as adrenaline tartrate).

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

Description of the appearance of CARTIDONT and contents of the pack
CARTIDONT is a clear and colourless 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 blocked by an aluminium cap.
Box containing 50 glass cartridges of 1.7 ml

Marketing Authorisation Holder and Manufacturer
CURASEPT S.p.A - Via G. Parini, 19 - CAP 21047, Saronno (VA), Italy

Manufacturer
Pierrel S.p.A. - Strada Statale Appia n. 46/48 - 81043 CAPUA (CE)

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The following information is intended exclusively for doctors or healthcare professionals
Dosage:
For all populations, the lowest effective dose capable of inducing
anaesthesia should be used. The necessary dosage must be determined on an individual basis.
For a routine procedure, the normal dose for adult patients is one cartridge, but the
contents of less than one cartridge may be sufficient to achieve effective anaesthesia.
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, CARTIDONT 40mg/ml + 5 micrograms/ml is preferred.
For more complex procedures, for example those requiring pronounced haemostasis,
CARTIDONT 40mg/ml +10 micrograms/ml is preferred,

Concomitant use of sedatives to reduce patient anxiety:
The safe maximum dose of local anaesthetic may be reduced in sedated patients
due to the additive effect of central nervous system depression.

Adults and adolescents (age between 12 and 18 years):
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 (age between 4 and 11 years):
The safety of CARTIDONT 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 anaesthesia should be used. In children 4 years of age (or at least 20 kg (44 lbs) of
body weight) and over, 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.

Special populations
Elderly and patients with renal impairment
Due to the lack of clinical data, particular precautions must be taken to administer the
lowest effective dose capable of inducing anaesthesia in elderly patients and those
with renal impairment.
Elevated plasma levels of the product may occur in these patients, especially
following repeated use. If repeated injection is necessary, the patient must be
carefully monitored to identify any signs of relative overdose.
Patients with hepatic impairment
Particular precautions must be taken to administer the lowest effective dose capable of
inducing anaesthesia in patients with hepatic impairment, in particular after repeated
use, although 90% of articaine is inactivated by non-specific plasma esterases in the
tissues and 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
inactivated by plasma esterases by 90%. Therefore, the lowest effective dose capable of
inducing anaesthesia should be used.

Route of administration
Infiltration and perineural use in the oral cavity.
Local anaesthetics must be injected with caution in the presence of inflammation and/or
infection at the injection site. The injection must be performed very slowly (1
ml/min).

Precautions to be taken before handling or administering the medicinal product

This medicinal product must be used only by doctors or dentists with
adequate knowledge and experience in the diagnosis and treatment of systemic toxicity or
under their supervision. Before inducing regional anaesthesia with local anaesthetics, 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 anaesthetic.
When using CARTIDONT for infiltration or loco-regional anaesthesia, the injection must
always be performed slowly and after aspiration.

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

Precautions for use

Risks associated with accidental intravascular injection
Accidental intravascular injection may cause a sudden increase in adrenaline and articaine
levels in the systemic circulation. This may be associated with serious adverse reactions,
for example, convulsions, 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 anaesthetic. 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 may cause the drug to rise along the nerve.
To avoid intraneural injection and prevent nerve injury related to nerve blocks, the needle
should be slightly retracted 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 neurotoxicity of articaine and the presence of adrenaline, as
this may reduce blood supply to the perineural area and prevent the elimination of articaine
locally.

Overdose treatment
Before administering regional anaesthesia with local anaesthetics, 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 timely protection of the airways and practice assisted
ventilation.
The patient’s state of consciousness must be monitored after each injection of
local anaesthetic.
If signs of acute systemic toxicity occur, the injection of local anaesthetic must be
immediately stopped. If necessary, place the patient in the supine position.
Symptoms of the CNS (convulsions, CNS depression) must be treated immediately by
appropriate respiratory/airway support and administration of anticonvulsant drugs.
Optimal oxygenation, ventilation and circulatory support, together with treatment of
acidosis, may prevent cardiac arrest.
In case of cardiovascular depression (hypotension, bradycardia), it is appropriate to
consider 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 colour.
To avoid the risk of infection (e.g. transmission of hepatitis), the syringes and
needles used to aspirate the solution must always be new and sterile.
The cartridges are for single use. If a cartridge is only partially used, discard the
remaining solution.
Unused medicine and waste derived from such medicine must be disposed of in
accordance with local regulations.