Articaine + adrenaline (epinephrine)

UBISTESIN and UBISTESIN FORTE are exclusively recommended for use in dentistry. As for any cartridge, the diaphragm should be disinfected just prior to use. It should be carefully swabbed: • Either with ethyl alcohol 70% • Or with pure isopropyl alcohol 90% for pharmaceutical use The cartridges should under no circumstances be dipped into any solution whatsoever. The solution for injection should not be mixed with any other product into the same syringe. No opened cartridge of anaesthetic solution should be reused. Dosage The smallest possible volume of solution which will lead to an effective anaesthesia should be used. Use in adults: Table 2 summarises the recommended volumes and concentrations of UBISTESIN and UBISTESIN FORTE for various types of anaesthetic procedures. For most common operations, one infiltration with UBISTESIN and UBISTESIN FORTE 1.7 mL is sufficient. In all cases, the injection must be done slowly (about 1 mL/minute). For an infiltration in the interdental …

Hypersensitivity to articaine (or any local anaesthetic agent of the amide type) or to adrenaline (epinephrine) or to any of the excipients (See Section 6.1 List of excipients) Phaeochromocytoma Uncontrolled hyperthyroidism Plasma cholinesterase deficiency Complete heart block not compensated by a pacemaker This product contains sodium sulfite, which may cause allergic reactions, including anaphylactic reactions and asthmatic episodes, in susceptible people Ubistesin and Ubistesin Forte CCDSv3 PIv3 25 February 2020 (see Section 4.4 Special warnings and precautions for use and Section 4.8 Adverse

Before using this medicinal product, it is important: -To make inquiries into the patient’s current therapies and history; -To maintain verbal contact with the patient; When any local anaesthetic agent is used, resuscitative equipment and resuscitative drugs, including oxygen, should be immediately available in order to manage possible adverse reactions involving the cardiovascular, respiratory or central nervous systems. Injection should always be made slowly with frequent aspirations to avoid inadvertent intravascular injection, which can produce cerebral symptoms even at low doses. (see Section 4.2 Dose and Method of Administration). Special warnings This product must be used with caution in; Patients with cardiovascular disorders:

• Uncontrolled/severe hypertension
• Severe ischemic heart disease
• Recent myocardial infarction
• Recent coronary artery bypass surgery
• Persistent/refractory tachyarrhythmia
• Atrioventricular block grade I, II and III; do not use in complete heart …

Due to the presence of articaine Interactions requiring precautions for use: Other local anaesthetics: Toxicity of local anaesthetics is additive. The total dose of all local anaesthetics administered should not exceed the maximum recommended dose of the drugs used. Cimetidine: Increased serum levels of amide anaesthetics have been reported after concomitant administration of cimetidine. Cimetidine may increase the cardiac and neurological effects of local anaesthetics. Sedatives (central nervous system depressants e.g. benzodiazepine, opioids): In children receiving benzodiazepines or opioids, reduced doses of this product should be used due to additive effects. Due to the presence of adrenaline Interactions requiring precautions for use: Halogenated volatile anaesthetics (e.g., halothane, enflurane): Reduced doses of this product should be used due to sensitisation of the heart to the arrhythmogenic effects of catecholamines, leading to the risk of severe ventricular …

a) Summary of the safety profile Adverse reactions following the administration of articaine / adrenaline (epinephrine) are similar to those observed with other local amide anaesthetics / vasoconstrictors. These adverse reactions are, in general, dose-related. They may also result from hypersensitivity, idiosyncrasy, diminished tolerance by the patient or unintentional intravascular injection. Nervous system disorders, local injection site reactions, hypersensitivity, cardiac disorders and vascular disorders are the most frequently occurring adverse reactions. Serious adverse reactions are generally systemic. Early symptoms and signs of CNS toxicity include metallic taste, tinnitus, lightheadedness and confusion, followed by tremors and shivering. Seizures and cardiorespiratory arrest may ultimately occur (see Section 4.9 Overdose). b) Tabulated list of adverse reactions The reported adverse reactions come from spontaneous reporting, clinical studies and literature. The frequencies …

The most serious effects of articaine intoxication are on the CNS and cardiovascular system. The type of toxic reaction is unpredictable and depends on such factors as dosage, rate of absorption, unintended intravascular injection and clinical status of the patient. To minimise the risk, the patient’s cardiovascular and respiratory vital signs and state of consciousness should be monitored after each injection. Two types of reactions that effect stimulation and/or depression of the central cortex and medulla may result from systemic absorption. • Slow onset symptoms following overdose include stimulation leading to restlessness, nervousness, dizziness, apprehension, light headedness paraesthesias, euphoria, logorrhoea, sweating, headache, blurred vision, tinnitus, nausea, vomiting, muscle twitching and tremors, nystagmus, tachypnoea, difficulty in swallowing, metallic taste, slurred speech and convulsions. Excitatory manifestations may not occur at all or may be …

Effects on fertility No effects on male or female fertility were observed in rats given articaine hydrochloride with adrenaline (epinephrine) subcutaneously from prior to mating until mating (males) or early gestation (females) at doses up to 80 mg/kg/day (approximately twice the maximum recommended human dose on a mg/m² basis). Use in pregnancy (Category B3) Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. No clinical experience of the use of articaine and adrenaline (epinephrine) injections in pregnant women is available. Safe use of local anaesthetics during pregnancy has not been established with respect to adverse effects on fetal development. The product should only be used in pregnancy when the benefits are considered to outweigh the risks. No effects on embryofetal development were observed when articaine hydrochloride with adrenaline (epinephrine) was administered …