SARTICAIN 40 mg /Ml + 10 Microgrammi/Ml Roztwór Do Wstrzykiwań

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1. SARTICAIN with adrenaline 1:100,000

SARTICAIN with adrenaline 1:100,000

40 mg/ml + 10mcg/ml injectable solution
SARTICAIN with adrenaline 1:200,000
40 mg/ml + 5mcg/ml injectable solution
PHARMACO-THERAPEUTIC CATEGORY
Local anesthetics, amides (articaine in association).

THERAPEUTIC INDICATIONS
Lexical, trunk or intraligamentous type anesthesia in case of:

SARTICAIN with Adrenaline 1:100,000:Deeper surgical interventions such as those on the mucous membranes,
on bone and on the dental pulp (amputation and extirpation) which require a more intense
ischemia of the tissues; extraction of teeth with apical periodontitis and fractured (osteotomy); surgical
interventions of long duration (for example: Caldwell-Luc operation, percutaneous osteosynthesis, cystectomy,
mucogingival interventions, complicated preparation of cavities and stumps for the application of crowns).

SARTICAIN with Adrenaline 1:200,000:routine interventions, such as extraction of single or multiple teeth,
preparation of cavities and demolition of stumps for the application of crowns, particularly in patients
debilitated.

CONTRAINDICATIONS
Hypersensitivity to the active ingredients or to any of the excipients or to another local anesthetic of the amidic type,
adrenaline.
As with all local anesthetics containing adrenaline, intravascular administration is strictly contraindicated. It is therefore absolutely necessary to ensure that the needle used
for the injection is not engaged in a vessel.
Contraindicated in patients treated with monoamine oxidase inhibitors (MAOIs), (or who have been treated
with such drugs in the last two weeks);
in patients taking tricyclic antidepressants;
in patients with myasthenia gravis or plasma cholinesterase deficiency;
in patients taking beta-blockers;
in children under four years of age;
in various cardiovascular disorders: recent myocardial infarction, rhythm disturbances, conduction disturbances,
uncompensated acute heart failure, hypertension;
in essential migraine;
in ascertained or presumed pregnancy; during breastfeeding,
The product should not be administered to asthmatics who present a hypersensitivity to sulfites.
Given the presence of adrenaline, the use of the product is contraindicated:
in diabetic subjects, in subjects suffering from closed-angle glaucoma, in subjects affected by
paroxysmal tachycardia and absolute arrhythmia with high frequency, in heart disease, in severe arteriopathies,
in hypertension, in ischemic manifestations of any kind, in nephropathies, in hyperthyroidism, in
diabetes, in thyrotoxicosis, in cases of pheochromocytoma, in cerebrovascular insufficiency.
Given the mechanism of metabolism and elimination, the administration of the product must be
accompanied by particular caution in case of renal and hepatic insufficiency, angina pectoris,
arteriosclerosis, epilepsy, respiratory failure, in blood coagulation disorders.
Never use the product in anesthesias at the level of the terminal circulatory zone.

PRECAUTIONS FOR USE
Before use, the doctor must ascertain the state of health of the patient and his circulatory conditions;
he must also inquire about ongoing therapies and any previous allergic reactions.
Any overdose of anesthetic must be avoided and never administer two maximum doses of
the latter without a minimum interval of 24 hours having elapsed.
It is necessary, however, to use the lowest doses and concentrations that can allow to obtain
the desired effect.
The anesthetic solution must be injected with caution in small doses after about 10 seconds from a
preventive aspiration.
Especially when infiltrating highly vascularized areas, it is advisable to wait about
two minutes before proceeding with the actual loco-regional block. The patient must be kept
under close monitoring, immediately suspending administration at the first sign of alarm (for
example, modification of sensory perception: burning, tingling, electric shock sensation).

It is necessary to have immediate availability of the equipment, drugs and personnel suitable
for the treatment of emergencies, as rare cases have been reported following the use of local anesthetics,
serious reactions, sometimes with fatal outcome, even in the absence of individual hypersensitivity.
Local anesthesia should be avoided in infected areas and in inflammation.
Like other amidic-type anesthetics metabolized by the hepatic microsomal system, cytochrome P-450,
Sarticain must be used with caution in patients with liver disease; patients with severe liver damage are more exposed to the risk of toxic plasma concentrations.
Sarticain must be administered with particular attention in subjects with a previous history of
epilepsy.

INTERACTIONS
Opioids routinely used for premedication and supplementary medication or other analgesics, atropine, psychotropic drugs or peripheral analeptics or, in case of supplementary general anesthesia, barbiturates, inhalation anesthetics, ketamine and
neuroleptanalgesics have not determined effects different from those desired.
Cimetidine and beta-blockers slow down the hepatic catabolism of local anesthetics; digitalis increases
the risk of bradycardia and disturbances of auriculo-vestibular conduction. In case of simultaneous
administration of non-cardioselective beta-blockers, an increase in blood pressure may occur
due to the adrenaline content in Sarticain (see Special warnings).
Digitalis increases the risk of bradycardia and disturbances of auriculo-vestibular conduction. Guanethidine enhances and prolongs the action of adrenaline; L-dopa, being a precursor of adrenaline,
can determine hypertensive attacks.
The hypertensive action of sympathomimetic vasoconstrictors, such as adrenaline, can be
potentiated by tricyclic antidepressants or MAOIs (see Contraindications). If treated with
such drugs, the product must be used with absolute caution. Interactions of this type have been reported
with the use of noradrenaline at a concentration of 1:25,000 and adrenaline at a concentration of
1:80,000; that contained in the two formulations of the product (1:100,000 and 1:200,000) is lower, however, the possibility of such an interference must be considered.

SPECIAL WARNINGS
Intravascular injection must be absolutely avoided. It is therefore necessary to ensure that the needle
used for the injection is not engaged in a blood vessel; accidental injection may be
associated with convulsions followed by depression of the central nervous system and/or
cardiorespiratory depression and coma.
To avoid bites to the lips, tongue and mucous membranes, the patient must be sensitized not to
chew anything before sensitivity returns.
Opened cartridges must not be reused (risk of hepatitis).

Attention: the product contains sodium sulfite anhydrous as a preservative: this substance can cause
in sensitive subjects and particularly in asthmatics, allergic reactions and severe asthmatic attacks.
The 20 ml vials contain para-hydroxybenzoate which can cause allergic reactions generally of the
delayed type, such as contact dermatitis; more rarely they can cause immediate-type reactions with urticaria
and bronchospasm.
Sarticain contains adrenaline which can cause local tissue necrosis and systemic toxicity, usual precautions must therefore be observed for the administration of adrenaline.
Attention for those who engage in sports activities: the product contains substances prohibited for doping.
Administration different from the dosage scheme and route of administration reported is prohibited.

Pregnancy and breastfeeding
Sarticain should not be administered in case of pregnancy or breastfeeding, as there is insufficient data
relating to the administration of the medicine, to women in labor and clinical data are not available if the active ingredients contained in the medicine pass into breast milk.

Effects on the ability to drive vehicles and operate machinery
Only the doctor can decide whether, after the intervention, the patient is in a safe condition to drive
vehicles or operate machinery.

DOSAGE, METHOD AND TIME OF ADMINISTRATION
For normal uncomplicated extractions of upper teeth in a non-inflammatory state, it is usually sufficient to inject into the vestibular fornix 1.7 ml (one cartridge) of product for each tooth.
Exceptionally, even to avoid the pain of palatal injection, a subsequent injection of 1 – 1.7 ml may be necessary. In cases where it is necessary to make an incision or suture in the palate, it is
sufficient to inject about 0.1 ml into the palate at a time.
In case of multiple extractions of adjacent teeth, in most cases the number of vestibular injections
can be reduced.
For normal uncomplicated extractions of lower premolars, trunk anesthesia can be avoided as
plexic anesthesia with a cartridge (1.7 ml) of product per tooth is sufficient. If complete anesthesia does not occur, it is advisable to make another injection of 1 – 1.7 ml in the vestibular seat. Only if even in this case the anesthetic effect was not complete, is the usual injection indicated
in the mandibular foramen.
For the preparation of cavities and demolition of stumps for the application of crowns, depending on the extent and
duration of the treatment, 0.5 to 1.7 ml of

SARTICAIN with Adrenaline 1:200,000per tooth in the vestibular seat are indicated. In cases of surgical interventions, SARTICAIN with Adrenaline 1:100,000at doses proportional to the severity and duration of the intervention is indicated.

OVERDOSE
Symptoms of intoxication
Excitation of the CNS: state of confusion, fear, tachypnea, tachycardia, increased pressure with
facial flushing, nausea, vomiting, tremor, spasms, trismus and convulsions.
Depression of the CNS: dizziness, loss of speech, hearing difficulties, loss of consciousness,
muscle contractions, vasomotor complications, difficulty breathing, death from respiratory arrest.
Cardiocirculatory depression: bradycardia, arrhythmia, fibrillation, hypotension, cardiac arrest, cyanosis.

Emergency measures and therapy
At the first sign of alarm, stop administration, place the patient in a horizontal position and ensure
patency of the airways by administering oxygen in case of severe dyspnea or
performing artificial ventilation (Ambu bag). The use of analeptics should be avoided so as not to
worsen the situation by increasing oxygen consumption. Any convulsions can be controlled
with the use of diazepam at a dose of 10 – 20 mg intravenously; barbiturates are instead not recommended as they
can accentuate the bulbous depression. Circulation can be supported by administering
corticosteroids in appropriate doses intravenously: diluted solutions of - vasoconstrictor agents (mefentermine, metaraminol and others) or atropine sulfate can be added.
Sodium bicarbonate in targeted concentration can be used as an acidifier, intravenously.

UNDESIRABLE EFFECTS
Toxic reactions and allergic reactions may occur to both the anesthetic and the vasoconstrictor.

Toxic reactions:undesirable effects resulting from high plasma levels have been described, affecting both the
central nervous system and the cardiovascular system. Effects on the central nervous system described
include: excitation, tremors, disorientation, dizziness, mydriasis, increased metabolism and body
temperature, and, for very high doses, trismus and convulsions; if the medulla oblongata is affected, there is
involvement of the cardiovascular, respiratory and emetic centers with sweating, arrhythmias, hypertension,
tachypnea, bronchodilation, nausea and vomiting. Peripheral-type effects on the cardiovascular
system include: bradycardia and vasodilation.
Allergic reactions occur mostly in hypersensitive individuals but many cases are reported with
no individual hypersensitivity in the medical history. Local manifestations include
skin rashes of various types, urticaria, itching; general manifestations include bronchospasm, laryngeal edema
up to cardiorespiratory collapse from anaphylactic shock.

Allergic reactions:local manifestations such as skin rashes of various types, urticaria, itching;
general manifestations such as bronchospasm, laryngeal edema, up to cardiorespiratory collapse
from anaphylactic shock.
The vasoconstrictor may determine effects of various types, especially in subjects with
cardiocirculatory problems: anxiety, sweating, labored breathing, cardiac arrhythmias, hypertension (particularly
severe in subjects who are already hypertensive and in hyperthyroid patients), acute headache, photophobia, retrosternal and pharyngeal pain,
vomiting; if symptoms of this type appear, administration should be stopped immediately.
The frequency classes of adverse reactions are defined as follows: very common (≥ 1/10); common (≥
1/100,<1>be estimated from available data).

Immune system disorders: Rare: allergic reactions, in the most severe cases, anaphylactic shock.

Psychiatric disorders: Rare: anxiety, nervousness.

Nervous system disorders: Common: headache.
Uncommon: paresthesia (loss of sensitivity and burning sensation) of the tongue, lip or
both, hypoesthesia.
Rare: Metallic taste, tinnitus, dizziness, restlessness, tremors, tachypnea, drowsiness, disorientation,
trismus, facial nerve paralysis, convulsions, muscle contractions, tonic-clonic convulsions, coma and
respiratory paralysis.

Eye disorders: Rare: diplopia, mydriasis, ptosis, miosis and enophthalmos, photophobia.

Cardiac disorders: Common: bradycardia, tachycardia
Uncommon: hypertension.
Rare: cardiovascular depression and cardiac arrest.

Gastrointestinal disorders: Uncommon: nausea and vomiting.

Skin and subcutaneous tissue disorders: Common: facial edema.
Uncommon: itching, urticaria.
Rare: angio-edema, necrosis.

Respiratory, thoracic and mediastinal disorders: Not known: tachypnea, bronchodilation, bronchospasm,
retrosternal and pharyngeal pain.

System disorders: Not known: increased metabolism and body temperature with sweating.
Pain and ulcers at the injection site.
Cases of paralysis of the eye muscles have been reported after posterior and superior alveolar injection
(during anesthesia); symptoms include diplopia, mydriasis, ptosis, difficulty with eye abduction. These
symptoms may appear immediately after the injection and persist from a few minutes to several hours.

EXPIRY DATE AND STORAGE
Expiry date: see the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.

Warning:Do not use the medicine after the expiry date printed on the packaging.
Store in the original packaging to protect the medicine from light. Store at
a temperature not exceeding 25°C, do not freeze.
Medicines should not be disposed of via drains or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment

KEEP THE MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.
COMPOSITION
SARTICAIN with adrenaline 1:100,000 40 mg/ml + 10mcg/ml injectable solution
1 ml of solution contains:

Active ingredients
Articaine hydrochloride 40,.00 mg
Adrenaline bitartrate 0.01 mg 18.2 micrograms
(corresponding to Adrenaline base 10 micrograms)

Excipients: Sodium chloride, anhydrous sodium sulfite, methylparahydroxybenzoate (only vials), Water p.p.i..for
injectable preparations.

SARTICAIN with adrenaline 1:200,000 40 mg/ml + 5mcg/ml injectable solution
1 ml of solution contains:
Articaine hydrochloride 40,.00 mg
Adrenaline bitartrate 0.005 mg 9.1 micrograms
(corresponding to Adrenaline base 5 micrograms)

Excipients: Sodium chloride, anhydrous sodium sulfite, methylparahydroxybenzoate (only vials), Water p.p.i..for
injectable preparations.

PHARMACEUTICAL FORM AND CONTENT
Injectable solution.

SARTICAIN with adrenaline 1:100,000 40 mg/ml + 10mcg/ml injectable solution
Pack of 50 cartridges of 1.7 ml.
Pack of 60 cartridges 1.7 ml.
Pack of 10 vials of 20 ml.

SARTICAIN with adrenaline 1:200,000 40 mg/ml + 5mcg/ml injectable solution
Pack of 50 cartridges of 1.7 ml.
Pack of 60 cartridges 1.7 ml.
Pack of 10 vials of 20 ml.

MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Industria Farmaceutica Galenica Senese srl - Via Cassia Nord, 351 - 53014 Monteroni d’Arbia (SI)

REVIEW OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY
16 May 2012