3M Health Care is now Solventum
XYLESTESIN-A 1/80 000 solution for injection is a Prescription Medicine. Therapeutic indications: Local anaesthesia (infiltration and nerve-block anaesthesia) in dentistry. Xylestesin-A is indicated in adults, children and adolescents. Xylestesin-A is exclusively recommended for use in dentistry.
Contraindications: Xylestesin-A must not be used in the event of ;- hypersensitivity to the active substances, sodium sulphite (E221) or to any of the excipients listed. Due to the active substance lidocaine (lignocaine), Xylestesin-A must not be used in the event of; − known allergy or hypersensitivity to local anaesthetics of the amide type, − severe, uncontrolled or untreated excitation and conduction disorders of the heart (e.g. grade II and III AV block, pronounced bradycardia), − acutely decompensated heart failure, − severe hypotension. Due to the content of adrenaline (epinephrine) as a vasoconstrictor admixture, Xylestesin-A must not be used in the event of; − Heart diseases such as: - unstable angina pectoris, - recent myocardial infarction, - recent coronary artery bypass surgery, - refractory arrhythmia and paroxysmal tachycardia or high-frequency, continuous arrhythmia, -untreated or uncontrolled severe hypertension, - untreated or uncontrolled congestive heart failure, − concomitant treatment with monoamine oxidase (MAO) inhibitors or tricyclic antidepressants. − Xylestesin-A must not be used in acra of extremities. Due to the content of sulphite as excipient, Xylestesin-A must not be used in the event of - allergy or hypersensitivity to sulphite, - severe bronchial asthma. Xylestesin-A can provoke acute allergic reactions with anaphylactic symptoms (e.g. bronchospasm).
Special warnings and precautions for use: Special warnings Xylestesin-A must be used with particular caution in the event of; − severely impaired renal and hepatic function,− angina pectoris, − arteriosclerosis, − considerably impaired blood coagulation or concomitant treatment with anticoagulants or platelet aggregation inhibitors. The overall risk of bleeding is increased. − haemorrhagic diathesis – increased bleeding risk particularly with nerve-block anaesthesia, − uncontrolled or untreated hyperthyroidism, − narrow-angle glaucoma, − diabetes mellitus, − lung diseases – particularly allergic bronchial asthma, − phaeochromocytoma, -methaemoglobinaemia, − impaired cardiovascular function due to decreased ability to compensate prolonged A-V conduction, − epilepsy (Avoid high doses!),− blood screening tests on athletes as Xylestesin-A may show positive results. Lidocaine (lignocaine) is not listed in the current WADA list. The listed adrenaline (epinephrine) can be used as a vasoconstrictor in local anaesthetics.
Precautions and Interactions with other medicines and other forms of interaction: Refer to datasheet for the extensive list.
Fertility, pregnancy and lactation: Pregnancy- There is limited data available on the use of Xylestesin-A in pregnant women. Lidocaine (lignocaine) animal studies do not indicate directly or indirectly harmful effects with respect to reproductive toxicity. Caution should be exercised when administering to pregnant women. Xylestesin-A should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Breast-feeding- A small ratio of lidocaine (lignocaine) is excreted into the breast milk but no effects on breast-fed neonates are likely at therapeutic doses. It is not known whether adrenaline (epinephrine) is excreted into the breast milk. Following anaesthesia with Xylestesin-A, breast-feeding mothers should discard the first human milk output before resuming breast-feeding. Fertility: Animal studies with high doses of lidocaine (lignocaine) or adrenaline (epinephrine) showed an effect on fertility (see section 5.3). At therapeutic doses of Xylestesin-A, however, no effects on male or female fertility are likely.
Effects on the ability to drive and use machines: In sensitive patients, injection of Xylestesin-A can lead to a transient impairment of responsiveness, e.g. when driving a vehicle.
Undesirable effects: - Summary of the safety profile: In general, the therapeutic use of Xylestesin-A can be regarded as very safe. The causality assessment in case of adverse events is difficult, as they may be due to the underlying dental disease, the dental procedure or the local anaesthetic and a clear differentiation is not possible. The description of the safety profile of Xylestesin-A is based on data identified in published clinical studies and on the postmarketing surveillance data of the manufacturer.
DOSE: Refer to datasheet for dosing and administration details.
For full information on dosage, contraindications, precautions, interactions and adverse effects please refer to the data sheet available at www.medsafe.govt.nz or by clicking on the link provided with this product. NZ Sponsor: 3M New Zealand Ltd, Auckland
NP21460 - Aug 2024