Solutions for Injection

Xylestesin™-ALocal Anaesthetics

it won’t hurtThe promise that

Local AnaestheticsSummary of Product Characteristics

ESSENTIAL INFORMATION: XYLESTESIN™-A; COMpOSITION: 1ml solution for injection contains: Active substances Lidocaine hydrochloride 20 mg, (R)-Epinephrine hydrochloride 0.015 mg (equivalent to 0.0125mg base) Excipients: Sodium sulphite max. 0.6 mg (corresponding to 0.31 mg SO2), Sodium chloride, Water for injections; ThERApEuTIC INdICATION: Infiltration anaesthesia and nerve-block in dentistry. CONTRAIN-dICATION: Due to lidocaine, XYLESTESIN-A cannot be used in the event of known allergy or hypersensitivity to local anaesthetics of the amide type; severe impairment of the nervous impulses and conduction system of the heart (e. g. grade II and III AV block, pronounced bradycardia); acutely decompensated cardiac insufficiency (acute failure of cardiac output); severe hypotension (very low blood pressure). Due to epinephrine, XYLESTESIN-A also cannot be used in the event of paroxysmal tachycardia or high-frequency, continuous arrhythmia; pronounced coronary insuf-ficiency; severe hypertension (high blood pressure); thyrotoxicosis (hyperactivity of the thyroid); narrow-angle glaucoma; decompensated diabetic metabolic condition; pheochromocytoma; concurrent treatment, or treatment during the past 14 days, with tricyclic antidepressants or monoamine oxidase (MAO) inhibitors. WARNING: XYLESTESIN-A must not be used in persons who are allergic or hypersensitive to sulphite, as well as in persons with severe bronchial asthma. In these persons, XYLESTESIN-A can provoke acute allergic reactions with anaphylactic symptoms (e. g. bronchospasm). uNdESIRAbLE EFFECTS: Due to lidocaine, the following side effects can occur from the use of XYLESTESIN-A: Milder central nervous symptoms involve metallic taste, tinnitus, dizziness, nausea, vomiting, restlessness, anxiety, initial increase in respiratory rate. More severe symptoms are drowsiness, confusion, tremor, muscle twitching, tonoclonic spasms, coma and respiratory paralysis. Severe cardiovascular episodes are seen in the form of a drop in blood pressure, asequence, bradycardia, cardiovascular arrest. Allergic reactions to lidocaine are most rare. undesirable effects which can occur due to epinephrine: Symptoms such as heat sensation, sweating, heart racing, headache, blood pressure increase, anginal disorders, tachycardias, tachyarrhythmias and cardiovascular arrest cannot be ruled out. SpECIAL WARNINGS: Due to the content of anhydrous sodium sulphite, allergic reactions or hypersensitivity reactions can ensue in isolated cases, particularly in bronchial asthmatics, which are manifested as vomiting, diarrhoea, wheezing, acute asthma attack, clouding of consciousness or shock. prescription: Information shortened. For further details please refer to the instructions for use. Date of revision of the text: January 2012; 3M Deutschland GmbH, Carl-Schurz-Straße 1, 41453 Neuss, Germany

Passionate aboutpainlessness

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3M Deutschland GmbHLocation Seefeld3M ESPE · ESPE Platz82229 Seefeld · Germanyinfo3mespe@mmm.comwww.3MESPE.com www.3MESPE.com

3M, ESPE, Espertise, Pluraject and Xylestesin are trademarks of 3M Company or 3M Deutschland GmbH. Used under license in Canada.

All other trademarks are owned by other companies.

© 2012, 3M. All rights reserved.

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Painlessness you can trust

How is the high quality of 3M ESPE local anaesthetics checked and safeguarded?

We bank on a double quality assurance: First, the washed and siliconized cartridges are filled by means of a laser-controlled process. This step guarantees a particularly high degree of freedom from bubbles. As an additional step, all cartridges pass through an optoelectronic control system to check them for visible particles in the solution, absence of bubbles, potential glass defects, correct position and size of stopper. Cartridges that do not meet the predetermined parameters are separated out and discarded. By this means, cartridges with air bubbles, for example, are prevented from being sold.

Xylestesin™-A for routine-type interventions

Contains 2 % lidocaine with adrenaline 1:80 000 as a vasoconstrictor

Infiltration and nerve-block anaesthesia for routine-type interventions

Only sulphite as a stabilizer

Appropriate for adults and children

Average duration of action: – Pulp anaesthesia: approx. 30–60 minutes – Soft-tissue anaesthesia: 120–180 minutes – Latency period of 1–3 minutes

Pluraject™ 2 aspiration syringes for cylindrical glass cartridges with perforated stoppers

Compact and lightweight for better handling Cartridges are easy to insert and remove thanks to the hinge mechanism Appropriate for both active and passive aspiration Inch and metric thread available

The pivotal 3M ESPE promise: top quality “Made in Germany”.

A basic requirement for all our solutions: they have to be the best, quality is essential. With 3M™ ESPE™, you have a partner dedicated to the highest possible standards. At our production site in Seefeld, Germany, peak performance is everyday business. Local anaesthetic solutions originate in an up-to-date production plant, where a major investment was made in a new filling facility for local anaesthetics.

Some more facts that underscore our strength and experience in this field: At number 2 worldwide in local anaesthetics, 3M ESPE produced more than one billion units in the past ten years. Our local anaesthetics are represented in 57 countries and contribute to safeguarding the future of almost 1,000 jobs in Seefeld. And that’s more than just numbers – it’s your guarantee of having a reliable partner.

Espertise™ – a lively hub of knowledge and information Exchanging relevant information with users is vital to our work. To create a common platform for this purpose, 3M ESPE has developed the Espertise program – to provide independent and objective information on trends and advances in dentistry. Of course, this also applies to the important field of local anaesthesia.

Espertise is the authoritative information resource for dental professionals and scientists, providing a variety of educational programs that disseminate current science–based knowledge and the latest news of products, trends and techniques in the dental industry.

Competence & Quality

Xylestesin™-A – our Lidocaine product that reflects all our experience.

With 3M ESPE Xylestisin-A, you can rely on an effective and well-tolerated compound that has proven itself millions of times in dental practice. Behind it stand more than 50 years of experience in the development of local anaesthetics – leading-edge know-how, which you and your patients can trust.

Programmed to ensure the dental state of art.Within the Espertise framework, we offer carefully thought-out programs of scientific services, including workshops and comprehensive expert information. The two local anaesthetics brochures on the left, which can be ordered for free, are exemplary for that:

Our Guide for the Dental Practice Emergency Management gives clear instructions and renders assistance for you and your team in case of emergencies in the practice.

Our Scientific Facts Booklet offers summaries of a Global Expert Conference dedicated to “No Pain – less stress” held in Munich in 2011.

Espertise™

Smart packaging – safe handling.

Even the packaging has been continuously refined. With a series of well-thought-out features, it is now more convenient than ever:

Cylindrical glass cartridges with inner silicone coating – for a smooth, gentle and controlled injection

Safety foil – prevents splintering

Packaging in a stable metal box with a padded interior – for safe transport, easy removal and tidy storage

Colour-coded aluminium caps – No chance of mix-ups! (3M™ ESPE™ Xylestesin™-A e. g. has a green cap.)

No splintering, because of safety foil and stable metal box. No cartridge was broken.

We help you strengthen confidence – by being a No Fear Practice.

If it doesn’t hurt, patients are not frightened, and that is the best possible advertising for your practice. So you’re invited to become a “No Fear Practice” and join our efforts to eliminate pain and stress from dental treatments: we will gladly send you the complete 3M ESPE No Fear Practice package for free, including flyers and waiting room posters with an appropriate addressing of patients’ concerns.

please call 0800 / XXXXXXX

Prof. Stanley F. Malamed, USA (2011).

“ Lidocaine developed in 1948 was a revolutionary drug at that

time and still remains the most used local anaesthetic in

medicine and dentistry, the “Gold Standard” to which any new

local anaesthetic is compared.”

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