Ropivacaine Bioavenir

/ BioAvenir

For epidural and perineural use. Ropivacaine Hydrochloride should only be used by, or under the supervision of, clinicians experienced in regional anaesthesia.
For dosage recommendations for Ropivacaine BioAvenir in adults and adolescents above 12 years of age, please refer to table 1 in the doctor’s leaflet. The table is a guide to dosage for the more commonly used blocks. The smallest dose required to produce an effective block should be used. The clinician’s experience and knowledge of the patient’s physical status are of importance when deciding the dose.
See prescribing information for full details.

Ropivacaine BioAvenir 2mg/ml solution for injection is indicated for acute pain management:
In adults and adolescents above 12 years of age for:
Continuous epidural infusion or intermittent bolus administration e.g. during post operative or labour pain.
Field blocks.
Peripheral nerve block via continuous infusion or intermittent bolus injections, e.g: postoperative pain management.
Ropivacaine BioAvenir 10mg/ml solution for injection is indicated in adults and adolescents above 12 years of age for:
Surgical anaesthesia: lumber epidural administration for surgery.

Hypersensitivity to the active substance or to any of the excipients or to other local anaesthetics of the amide type. General contra-indications related to epidural anesthesia, regardless of the local anaesthetic used, should be taken into account. Intravenous regional anaesthesia. Obstetric paracervical anaesthesia. Hypovolaemia.

Regional anaesthetic procedures should always be performed in a properly equipped and staffed area.
Equipment and medicinal products 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 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.
See prescribing information for full details.

The adverse reaction profile for Ropivacaine is similar to those for other long acting local anaesthetics of the amide type. Adverse reactions should be distinguished from the physiological effects of the nerve block itself e.g. Hypotension (a decrease in blood pressure), bradycardia during spinal/ epidural block.
Very common: Hypotension.
Common: Paraesthesia, dizziness, headache, Bradycardia, tachycardia, Hypertension, Vomiting, Urinary retention, Temperature elevation, rigor, back pain.

Ropivacaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics, e.g. certain antiarrhythmics, such as lidocaine and mexiletine, since the systemic toxic effects are additive. Simultaneous use of Ropivacaine with general anaesthetics or opioids may potentiate each others (adverse) effects. Specific interaction studies with ropivacaine and anti-arrhythmic active substances class III (eg, amiodarone) have not been performed, but caution is advised.
Cytochrome P450 (CYP) 1A2 is involved in the formation of 3-hydroxy ropivacaine, the major metabolite. In vivo the plasma clearance of ropivacaine was reduced by up to 77% during coadministration of fluvoxamine, a selective, potent and competitive CYP1A2 inhibitor. Thus strong inhibitors of CYP1A2, such as fluvoxamine and enoxacin, given concomitantly during prolonged administration of Ropivacaine, can interact with Ropivacaine. Prolonged administration of ropivacaine should be avoided in patients concomitantly treated with strong CYP1A2 inhibitors.
In vivo the plasma clearance of ropivacaine was reduced by 15 % during coadministration of ketoconazole, a selective and potent inhibitor of CYP3A4. However the inhibition of this isozyme is not likely to have clinical relevance.
In vitro ropivacaine is a competitive inhibitor of CYP2D6 but does not seem to inhibit this isozyme at clinically attained plasma concentrations.

Pregnancy: Apart from epidural administration for obstetrical use, there are no adequate data on the use of ropivacaine in human pregnancy. Experimental animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fœtal development, parturition or postnatal development.
Lactation: There are no data available concerning the excertion of ropivacaine into human milk.

Symptoms: Accidental intravascular injections of local anaesthetics may cause immediate (within seconds to a few minutes) systemic toxic reactions. In the event of overdose, peak plasma concentrations may not be reached for one to two hours, depending on the site of the injection, and signs of toxicity may thus
be delayed.
Treatment: If signs of acute systemic toxicity appear, injection of the local anaesthetic should be stopped immediately and CNS symptoms (convulsions, CNS depression) must promptly be treated with appropriate airway/respiratory support and the administration of anticonvulsant drugs.
If circulatory arrest should occur, immediate cardiopulmonary resuscitation should be instituted.
Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance.
If cardiovascular depression occurs (hypotension, bradycardia), appropriate treatment with intravenous fluids, vasopressor, and or inotropic agents should be considered. Children should be given doses commensurate with age and weight.
Should cardiac arrest occur, a successful outcome may require prolonged resuscitative efforts.

Incompatibilities: Studies carried out on alkaline solutions, showed that ropivacaine has poor solubility at pH> 6.0 and therefore precipitation may occur.
Shelf-life: 2 years.
Storage: Do not store above 25°C. Do not refrigerate or freeze.