CHIROCAINE Solution for injection Ref.[9273] Active ingredients: Levobupivacaine

Levobupivacaine should be administered only by, or under the supervision of, a clinician having the necessary training and experience.

The table below is a guide to dosage for the more commonly used blocks. For analgesia (e.g. epidural administration for pain management), the lower concentrations and doses are recommended. Where profound or prolonged anaesthesia is required with dense motor block (e.g. epidural or peribulbar block), the higher concentrations may be used. Careful aspiration before and during injection is recommended to prevent intravascular injection.

There is limited safety experience with levobupivacaine therapy for periods exceeding 24 hours. In order to minimise the risk for severe neurological complications, the patient and the duration of administration of levobupivacaine should be closely monitored (see section 4.4).

Aspiration should be repeated before and during administration of a bolus dose, which should be injected slowly and in incremental doses, at a rate of 7.5–30 mg/min, while closely observing the patient’s vital functions and maintaining verbal contact.

If toxic symptoms occur, the injection should be stopped immediately.

Maximum dose

The maximum dosage must be determined by evaluating the size and physical status of the patient, together with the concentration of the agent and the area and route of administration. Individual variation in onset and duration of block does occur. Experience from clinical studies shows onset of sensory block adequate for surgery in 10-15 minutes following epidural administration, with a time to regression in the range of 6-9 hours.

The recommended maximum single dose is 150 mg. Where sustained motor and sensory block are required for a prolonged procedure, additional doses may be required. The maximum recommended dose during a 24 hour period is 400 mg. For post-operative pain management, the dose should not exceed 18.75 mg/hour.

Obstetrics

For caesarean section, higher concentrations than the 5.0 mg/ml solution should not be used (see section 4.3). The maximum recommended dose is 150 mg.

For labour analgesia by epidural infusion, the dose should not exceed 12.5 mg/hour.

Paediatric population

In children, the maximum recommended dose for analgesia (ilioinguinal/iliohypogastric blocks) is 1.25 mg/kg/side. The maximum dosage should be adjusted according to the size, body constitution and physical status of the patient/child.

The safety and efficacy of levobupivacaine in children for other indications have not been established.

Special populations

Debilitated, elderly or acutely ill patients should be given reduced doses of levobupivacaine commensurate with their physical status.

In the management of post-operative pain, the dose given during surgery must be taken into account.

There are no relevant data in patients with hepatic impairment (see sections 4.4 and 5.2).

Table of Doses:

¹ Levobupivacaine solution for injection/concentration for solution for infusion is available in 2.5, 5.0 and 7.5 mg/ml solutions.
² Spread over 5 minutes (see also text).
³ Given over 15-20 minutes.
⁴ No data are available in paediatric population <6 months of age.
⁵ In cases where levobupivacaine is combined with other agents e.g. opioids in pain management, the levobupivacaine dose should be reduced and use of a lower concentration (e.g. 1.25 mg/ml) is preferable.
⁶ The minimum recommended interval between intermittent injections is 15 minutes.
⁷ For information on dilution, see section 6.6.

Accidental intravascular injection of local anaesthetics may cause immediate toxic reactions. In the event of overdose, peak plasma concentrations may not be reached until 2 hours after administration depending upon the injection site and, therefore, signs of toxicity may be delayed. The effects of the drug may be prolonged.

Systemic adverse reactions following overdose or accidental intravascular injection reported with long acting local anaesthetic agents involve both CNS and cardiovascular effects.

CNS Effects

Convulsions should be treated immediately with intravenous thiopentone or diazepam titrated as necessary. Thiopentone and diazepam also depress central nervous system, respiratory and cardiac function. Therefore their use may result in apnoea. Neuro-muscular blockers may be used only if the clinician is confident of maintaining a patent airway and managing a fully paralysed patient.

If not treated promptly, convulsions with subsequent hypoxia and hypercarbia plus myocardial depression from the effects of the local anaesthetic on the heart, may result in cardiac arrhythmias, ventricular fibrillation or cardiac arrest.

Cardiovascular Effects

Hypotension may be prevented or attenuated by pre-treatment with a fluid load and/or the use of vasopressors. If hypotension occurs it should be treated with intravenous crystalloids or colloids and/or incremental doses of a vasopressor such as ephedrine 5-10 mg. Any coexisting causes of hypotension should be rapidly treated.

If severe bradycardia occurs, treatment with atropine 0.3-1.0 mg will normally restore the heart rate to an acceptable level.

Cardiac arrhythmia should be treated as required and ventricular fibrillation should be treated by cardioversion.

Shelf life

Shelf life as packaged for sale: 3 years.

Shelf life after first opening: The product should be used immediately.

Shelf life after dilution in sodium chloride solution 0.9%: Chemical and physical in-use stability has been demonstrated for 7 days at 20-22°C. Chemical and physical in-use stability with clonidine, morphine or fentanyl has been demonstrated for 40 hours at 20-22°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Polypropylene ampoules: polypropylene ampoules do not require any special storage conditions.

For storage conditions of the reconstituted medicinal product, see section 6.3.

Chirocaine is available in two presentations:

• 10 ml polypropylene ampoule in packs of 5, 10 & 20
• 10 ml polypropylene ampoule, in sterile blister packs of 5, 10 & 20

Not all pack sizes may be marketed.

For single use only. Discard any unused solution.

The solution/dilution should be inspected visually prior to use. Only clear solutions without visible particles should be used.

A sterile blister container should be chosen when a sterile ampoule surface is required. Ampoule surface is not sterile if sterile blister is pierced.

Dilutions of levobupivacaine standard solutions should be made with sodium chloride 9 mg/ml (0.9%) solution for injection using aseptic techniques.

Clonidine 8.4 μg/ml, morphine 0.05 mg/ml and fentanyl 4 μg/ml have been shown to be compatible with levobupivacaine in sodium chloride 9 mg/ml (0.9%) solution for injection.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.