Revision Year: 2013
SCANDONEST 3% PLAIN is a local anaesthetic indicated for the local and loco-regional anaesthesia in dental surgery in adults, in adolescents and in children above 4 years of age (c.a. 20 kg of body weight).
SCANDONEST 3% PLAIN is particularly indicated when the use of vasoconstrictor is contraindicated.
For professional use by dentists and stomatologists.
As occurs with all local anaesthetics, doses vary and depend on the area to be anaesthetised, on the vascularity of tissues, on the number of nerve segments to be blocked, on the individual tolerance and on the technique of anaesthesia. The lowest volume of injection leading to effective local anaesthesia should be administered. The necessary dosage must be determined on an individual basis.
Various volumes may be used provided that the total maximum recommended dose is not exceeded.
For a healthy adult of 70 kg, the maximum dose of mepivacaine administered by submucosal infiltration and/or nervous block should not exceed 4.4 mg/kg (0.15 ml/kg) of body weight with an absolute dose of 300 mg mepivacaine per session.
The maximum recommended doses are reported in the following table depending on the cartridge volume and on the patient’s weight.
| Equivalent in cartridge numbers | |||
|---|---|---|---|
| Weight (kg) | Mepivacaine dose (mg) | Volume (ml) | 1.8 ml |
| 50 | 220 | 7.3 | 4.1 |
| 60 | 264 | 8.8 | 4.9 |
| 70 | 300 | 10.0 | 5.6 |
| 80 | 300 | 10.0 | 5.6 |
| 90 | 300 | 10.0 | 5.6 |
| 100 | 300 | 10.0 | 5.6 |
Children from 4 years of age (ca. 20kg body weight) and older (see 4.3).
Recommended therapeutic dose: The quantity to be injected should be determined by the age and weight of the child and by the magnitude of the operation. The average dosage is 0.75 mg/kg =0.025 ml of mepivacaine solution per kg body weight.
Maximum recommended dosage: Do not exceed the equivalent of 3 mg mepivacaine/kg (0.1 ml mepivacaine/kg) of body weight.
The table below illustrates the maximum recommended dose:
| Equivalent in cartridge numbers | |||
|---|---|---|---|
| Weight (kg) | Mepivacaine dose (mg) | Volume (ml) | 1.8 ml |
| 20 | 60 | 2 | 1.1 |
| 30 | 90 | 3 | 1.7 |
| 40 | 120 | 4 | 2.2 |
| 50 | 150 | 5 | 2.8 |
Due to the lack of clinical data, particular precaution should be used in order to administer the lowest dose leading to efficient anaesthesia in:
Infiltration and perineural use in oral cavity.
The rate of injection should not exceed 1 ml of solution per minute.
Local anaesthetic overdose in the largest sense is often used to describe:
The symptoms are dose-dependent and have progressive severity in the realm of neurological manifestations, followed by vascular toxicity, respiratory toxicity, and finally cardiac toxicity (detailed in section 4.8).
The availability of resuscitation equipment should be ensured before the onset of dental anaesthesia with local anaesthetics.
If acute toxicity is suspected, the injection of SCANDONEST 3% PLAIN must immediately be stopped.
Oxygen should rapidly be administered, if necessary assisted ventilation should be used. Change patient position to supine position if necessary.
In case of cardiac arrest, immediate initiation of cardiopulmonary resuscitation should be performed.
36 months.
Do no store above 25°C.
In order to protect from light, keep the cartridge in the outer carton tightly closed.
Do not freeze.
Type I glass cartridge, sealed at its base by a mobile type I synthetic rubber and at the top by a type I synthetic rubber seal kept in place by a metal cap.
Cartridges of 1.8 ml.
Box containing 50 cartridges.
Not all pack sizes may be marketed.
As for any cartridge, the diaphragm should be disinfected prior to use. It should be carefully swabbed:
The cartridges should under no circumstance be dipped into any solution whatsoever.
One cartridge can only be used for one single patient during one single session.
No opened cartridge of anaesthetic solution should be reused. If only a part is used, the remainder must be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements.
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