ROPIVACAINE B.BRAUN SOLUTION FOR INJECTION AND INFUSION 2MG/ML [SIN17164P]

Product Info

ROPIVACAINE B.BRAUN SOLUTION FOR INJECTION AND INFUSION 2MG/ML

[SIN17164P]

4.1. Therapeutic indications

a. Acute pain management in adults and adolescents (> 12 years of age):

• Continuous epidural infusion or intermittent bolus administration during postoperative or labour pain

• Field blocks

• Continuous peripheral nerve block via a continuous infusion or intermittent bolus injections, e.g. postoperative pain management

There are no safety or efficacy data to support the use of ropivacaine administered epidurally for analgesia for longer than 72 hours. Data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections support the use for up to 48 hours only.

b. Acute pain management in paediatrics (for peri- and post-operative pain management):

• Caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years

• Continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years

There are no safety or efficacy data to support the use of ropivacaine administered epidurally for analgesia for longer than 72 hours.

4.2. Posology and method of administration

Ropivacaine hydrochloride should only be used by or under the supervision of clinicians experienced in regional anaesthesia.

Posology

Adults and adolescents above 12 years of age
The following table is a guide to dosage for the more commonly used blocks in the average adult. Standard textbooks should be consulted for factors affecting specific block techniques and for individual patient requirements. 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 on the dose.

When prolonged blocks are used, either through continuous infusion or through repeated bolus administration, the risks of reaching a toxic plasma concentration or inducing local neural injury must be considered. Cumulative doses of up to 675 mg ropivacaine hydrochloride for surgery and postoperative analgesia administered over 24 hours were well tolerated in adults, as were postoperative continuous epidural infusions at rates of up to 28 mg/hour ropivacaine hydrochloride for 72 hours. In a limited number of patients, higher doses of up to 800 mg/day have been administered with relatively few adverse reactions.

Paediatric population

The dose in the table should be regarded as a guideline for use in paediatrics. Individual variations occur. Dosing recommendations can be given for children with a bodyweight up to 25 kg. A total volume of 25 ml should not be exceeded for single caudal epidural block and the volume for epidural bolus application. For children with a higher bodyweight no data is available to give detailed recommendations. In children with a high body weight, a gradual reduction of the dosage is often necessary and should be based on the ideal body weight. Standard textbooks should be consulted for factors affecting specific block techniques and for individual patient requirements.

The use of ropivacaine hydrochloride in preterm newborn infants is not established.

Method of administration
For perineural and epidural use.
Careful aspiration before and during injection is recommended to prevent intravascular injection. When a large dose is to be injected, a test dose of lidocaine with adrenaline (epinephrine) is recommended. An inadvertent intravascular injection may be recognised by a temporary increase in heart rate and an accidental intrathecal injection by signs of a spinal block.

Ropivacaine hydrochloride should be injected slowly or in incremental doses, at a rate of 25–50 mg/min, while closely observing the patient’s vital functions and maintaining verbal contact. If toxic symptoms occur, the injection should be stopped immediately.

4.3. Contraindications

• Hypersensitivity to ropivacaine, to other local anaesthetics of the amide type or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

• Intravenous regional anaesthesia (Bier’s block)

• Obstetric paracervical anaesthesia

• Hypovolaemia

• Intravenous administration

General contraindications related to regional anaesthesia, including neuraxial anaesthesia, should be taken into account.