Posology : מינונים

4.2      Posology and method of administration
LIDOCADREN TEVA is intended for use in adults, adolescents and children above 4 years of age.


Posology
The dosage should be adjusted individually according to the area to be anaesthetised, vascularisation of the tissues and anaesthetic technique to be used.
The recommended doses according to the technique used are described in the table below.

Anaesthetic        Recommended              Adults                    Children technique              dose               (70 kg)        20 kg-child        40 kg-child Infiltrations or   in ml of solution          1 ml            0.3 ml             0.6 ml terminal            in mg of
20 mg            6 mg              12 mg anaesthesia        lidocaine HCl in ml of solution        1.5 – 2 ml      0.4 – 0.6 ml       0.8 – 1 ml Truncal in mg of anaesthesia                               30 – 40 mg       8 – 12 mg          16 – 20 mg lidocaine HCl


LIDOCADREN TEVA Updated Working Copy         27. 7. 2015, RH
Maximum dose
Adults:
The maximum dose over a period of 24 hours is 490 mg of lidocaine (for a person of 70 kg), which must not exceed 7 mg/kg of body weight in adults.

Children:
The dose will be adjusted according to the patient’s age and weight, as well as the type of surgery to be performed, not exceeding 5 mg/kg of body weight.
The use of LIDOCADREN TEVA is contraindicated in children under 4 years of age.

Lidocadren TEVA is indicated for use in adults and in children older than 4 years of age. The amount to be injected should be determined by the age and weight of the child and the scale of the operation. The anaesthetic technique must be carefully selected. Painful anaesthetic techniques should be avoided. The behaviour of children must be monitored carefully during treatment. The mean dose for use is in the range 20 mg to 30 mg lidocaine hydrochloride per session.
Alternatively, the dose in mg of lidocaine hydrochloride that can be administered in children can be calculated using the expression: weight of child (in kilogrammes) x 1.33. Do not exceed the equivalent of 5 mg lidocaine hydrochloride per kilogramme body weight.

Special population:
Increased plasma levels of LIDOCADREN TEVA can occur in older patients due to diminished metabolic processes and lower distribution volume.

The risk of accumulation of LIDOCADREN TEVA is increased in particular after repeated application. A similar effect can ensue from severely impaired hepatic function (see section 4.4.), thus a lower dose is recommended in these cases.

Method of administration
For injection/oromucosal use.
For use in dental anaesthesia only.
To avoid intravascular injection, aspiration control at least in two planes (rotation of the needle by 180°) must always be carefully undertaken. The injection rate should not exceed 0.5 ml in 15 seconds, i.e. 1 cartridge per minute.