Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Regional anaesthetic procedures should always be performed in a properly equipped and staffed area.
Equipment and drugs necessary for monitoring and emergency resuscitation should be immediately available. Patients receiving major blocks should be in an optimal condition and have an intravenous line inserted before the blocking procedure. The clinician responsible should take the necessary precautions to avoid intravascular injection and be appropriately trained and familiar with diagnosis and treatment of side effects, systemic toxicity and other complications (See sections 4.8 Undesirable effects and 4.9 Overdose) such as inadvertent subarachnoid injection which may produce a high spinal block with apnoea and hypotension. Convulsions have occurred most often after brachial plexus block and epidural block. This is likely to be the result of either accidental intravascular injection or rapid absorption from the injection site.
Caution is required to prevent injections in inflamed areas.

Cardiovascular

Epidural and intrathecal anaesthesia may lead to hypotension and bradycardia. Hypotension should be treated promptly with a vasopressor intravenously, and with an adequate vascular filling.

Patients treated with anti-arrhythmic drugs class III (e.g., amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive.
There have been rare reports of cardiac arrest during the use of Ropivacaine for epidural anaesthesia or peripheral nerve blockade, especially after unintentional accidental intravascular administration in elderly patients and in patients with concomitant heart disease. In some instances, resuscitation has been difficult. Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the possibility of a successful outcome.

Head and neck blocks
Certain local anaesthetic procedures, such as injections in the head and neck regions, may be associated with a higher frequency of serious adverse reactions, regardless of the local anaesthetic used.

Major peripheral nerve blocks
Major peripheral nerve blocks may imply the administration of a large volume of local anaesthetic in highly vascularized areas, often close to large vessels where there is an increased risk of intravascular injection and/or rapid systemic absorption, which can lead to high plasma concentrations.

Hypersensitivity
A possible cross-hypersensitivity with other amide-type local anaesthetics should be taken into account.

Hypovolaemia
Patients with hypovolaemia due to any cause can develop sudden and severe hypotension during epidural anaesthesia, regardless of the local anaesthetic used.

Patients in poor general health
Patients in poor general condition due to ageing or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention, although regional anaesthesia is frequently indicated in these patients.

Patient with hepatic and renal impairment
Ropivacaine is metabolised in the liver and should therefore be used with caution in patients with severe liver disease; repeated doses may need to be reduced due to delayed elimination. Normally there is no need to modify the dose in patients with impaired renal function when used for single dose or short term treatment. Acidosis and reduced plasma protein concentration, frequently seen in patients with chronic renal failure, may increase the risk of systemic toxicity.

Acute porphyria
Ropivacaine solution for injection and infusion is possibly porphyrinogenic and should only be prescribed to patients with acute porphyria when no safer alternative is available. Appropriate precautions should be taken in the case of vulnerable patients, according to standard textbooks and/or in consultation with disease area experts.


Chondrolysis
There have been post-marketing reports of chondrolysis in patients receiving post-operative intra-articular continuous infusion of local anaesthetics, including ropivacaine. The majority of reported cases of chondrolysis have involved the shoulder joint. Intra-articular continuous infusion is not an approved indication for Ropivacaine BioAvenir. Intra-articular continuous infusion with Ropivacaine BioAvenir should be avoided, as the efficacy and safety has not been established.

Excipients with recognised action/effect
This medicinal product contains 3 mg sodium per ml. To be taken into consideration by patients on a controlled sodium diet.
Prolonged administration
Prolonged administration of ropivacaine should be avoided in patients concomitantly treated with strong CYP1A2 inhibitors, such as fluvoxamine and enoxacin, (See section 4.5).

Effects on Driving

4.7 Effects on ability to drive and use machines
No data are available. Depending on the dose, local anaesthetics may have a minor influence on mental function and coordination even in the absence of overt CNS toxicity and may temporarily impair locomotion and alertness.