AMPRES

g. maintaining the patency of the airways and administering oxygen, must be immediately available, since in rare cases severe reactions, sometimes with a fatal outcome, have been reported after using local anaesthetics, even in the absence of individual hypersensitivity in the patient’s case history.

The doctor in charge is responsible for taking the measures needed to avoid an intravascular injection and should be fully trained in emergency medicine and resuscitation to be ready to prevent and to treat the side effects and complication of the procedure.

Posology Posology must be established on an individual basis in accordance with the characteristics of the specific case. When determining the dose, the patient’s physical condition and the concomitant administration of other medicinal products should be taken into consideration.

The indications relating to recommended doses are valid in adults of average height and weight (approximately 70 kg) for obtaining an effective block with one single administration. There are wide individual variations with regard to extent and duration of action.

The experience of the anaesthetist and knowledge of the patient’s general condition are essential for establishing the dose.

With regard to posology the following guidelines are applied:

Posology Adults ml mg Average duration of action (minutes)Extension of sensory blockade required T10 4 5 40 50 80 100 The maximum recommended dose is 50mg (=5ml) of chloroprocaine hydrochloride. The duration of action is dose-dependent Special populations The clinician's experience and knowledge of the patient's physical status are of importance when deciding the dose.

It is advisable to reduce the dose in patients in a compromised general condition. g. vascular occlusion, arteriosclerosis, diabetic polyneuropathy) a reduced dose is indicated. Paediatric population The safety and efficacy of Ampres in children and adolescents have not been established.

1). Method of administration For intrathecal use. Ampres should be injected via the intrathecal route into the intervertebral space L2/L3, L3/L4 and L4/L5. The entire dose should be injected slowly, after having aspirated a minimum quantity of CSF to confirm the correct position.

Summary of safety profile The possible undesirable effects due to the use of Ampres are generally similar to the undesirable effects of other local anaesthetics for spinal anaesthesia from the ester group. g. g. g. g. post-spinal headache).

Tabulated summary of adverse reactions The adverse reactions listed below in Table 1 are classified according to System Organ Class. The frequency of undesirable effects listed below is defined using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).

Table 1 – Adverse reactions Very common Common Uncommon Rare Very Rare Immune system disorders allergic reactions as a result of sensitivity to the local anaesthetic: characterized by signs such as urticaria, pruritus, erythema, angioneurotic oedema with possible airway obstruction (including laryngeal oedema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly, anaphylactoid type symptomatology (including severe hypotension) Injury, Poisoning and Procedural Complications anaesthetic complication.

Nervous system disorders anxiety, restlessness, paraesthesia, dizziness signs and symptoms of CNS toxicity (backache, headache, tremors possibly proceeding to convulsions, convulsions, circumoral paraesthesia, feeling of numbness affecting the tongue, hearing problems, visual problems, blurred vision, shaking, tinnitus, speech problems, loss of consciousness).

neuropathy, drowsiness merging into unconsciousness and respiratory arrest, spinal block of varying magnitude (including total spinal block), hypotension secondary to spinal block, loss of bladder and bowel control, and loss of perineal sensation and sexual function, arachnoiditis, persistent motor, sensory and/or autonomic (sphincter control) deficit of some lower spinal segments with slow recovery (several months), cauda equina syndrome and permanent neurological injury.

g. amiodarone). 5), • In patients with acute porphyria, Ampres should only be administered when there is a compelling indication for its use, as Ampres may potentially precipitate porphyria. Appropriate precautions should be taken in all patients with porphyria, • Since ester-type local anaesthetics are hydrolysed by plasma cholinesterase produced by the liver, chloroprocaine should be used cautiously in patients with advanced hepatic disease, • Patients with genetic deficiency of plasma cholinesterase.

Ensuring the presence of reliable venous access is mandatory. In high risk patients, the recommendation is to improve their general condition prior to the intervention. A rare, but serious, undesirable effect of spinal anaesthesia is high or total spinal block, with consequent cardiovascular and respiratory depression.

Cardiovascular depression is induced by an extended block of the sympathetic nervous system, which may induce severe hypotension and bradycardia to the point of cardiac arrest. Respiratory depression is induced by the block of the respiratory musculature and the diaphragm.

Especially in elderly patients there is an increased risk of high or total spinal block: consequently it is advisable to reduce the anaesthetic dose. Particularly in the case of elderly patients, an unexpected drop in arterial pressure may occur as a complication of spinal anaesthesia.

Rarely, neurological damage may occur after spinal anaesthesia, manifesting as paraesthesia, loss of sensitivity, motor weakness, paralysis, cauda equina syndrome and permanent neurological injury. Occasionally these symptoms persist.

There is no suspicion that neurological disorders, such as multiple sclerosis, hemiplegia, paraplegia or neuromuscular disorders may be negatively influenced by spinal anaesthesia. Nevertheless, it should be used with care. Careful evaluation of the risk-benefit ratio is recommended prior to treatment.

g. decompensated cardiac insufficiency, hypovolemic shock), • intravenous regional anaesthesia (the anaesthetic agent is introduced into the limb and allowed to set in while tourniquets retain the agent within the desired area), • serious problems with cardiac conduction, • severe anaemia, • patients taking anticoagulants or with congenital or acquired bleeding disorder.