Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Sintetica Limited, 30<sup>th</sup> Floor, 40 Bank Street, Canary Wharf, London, E14 5NR, United Kingdom
Ropivacaine 2 mg/ml solution for infusion is indicated for acute pain management.
In adults and children above 12 years of age:
In infants from 1 year and children up to and including 12 years for:
In neonates, infants and children up to and including 12 years for (per- and postoperative):
Ropivacaine should only be used by, or under the supervision, of clinicians experienced in regional anaesthesia.
The following 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.
| Indication | Concentration mg/ml | Volume ml | Dose mg | Onset minutes | Duration hours |
|---|---|---|---|---|---|
| Lumbar Epidural Administration | |||||
| Bolus | 2.0 | 10-20 | 20-40 | 10-15 | 0.5-1.5 |
| Intermittent injections (top-up) (e.g. labour pain management) | 2.0 | 10-15 (minimum interval 30 minutes) | 20-30 | -- | -- |
| Continuous infusion e.g. labour pain | 2.0 | 6-10 ml/h | 12-20 mg/h | -- | -- |
| Postoperative pain management | 2.0 | 6-14 ml/h | 12-28 mg/h | -- | -- |
| Thoracic Epidural Administration | |||||
| Continuous infusion (postoperative pain management) | 2.0 | 6-14 ml/h | 12-28 mg/h | -- | -- |
| Field Block | |||||
| e.g. minor nerve blocks and infiltration | 2.0 | 1-100 | 2.0-200 | 1-5 | 2-6 |
| Peripheral nerve block | |||||
| Femoral or interscalene block | |||||
| Continuous infusion or intermittent injections (e.g. postoperative pain management) | 2.0 | 5-10 ml/h | 10-20 mg/h | -- | -- |
The doses in the table are those considered to be necessary to produce a successful block and should be regarded as guidelines for use in adults. Individual variations in onset and duration occur. The figures in the column ‘Dose’ reflect the expected average dose range needed. Standard textbooks should be consulted for both factors affecting specific block techniques and individual patient requirements.
Perineural and epidural administration by infusion.
Careful aspiration before and during injection is recommended to prevent intravascular injection. When a large dose is to be injected, a test dose of 3-5 ml lidocaine 2% (lignocaine) with adrenaline (epinephrine) 1:200.000 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.
Aspiration should be performed prior to and during administration of the main dose, which 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 infusion should be stopped immediately.
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 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 up to 28 mg/hour 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.
For treatment of postoperative pain, the following technique can be recommended: Unless preoperatively instituted, an epidural block with Ropivacaine 7.5 mg/ml is induced via an epidural catheter. Analgesia is maintained with Ropivacaine 2 mg/ml infusion. Infusion rates of 6-14 ml (12-28 mg), per hour provide adequate analgesia with only slight and non-progressive motor block in most cases of moderate to severe postoperative pain. The maximum duration of epidural block is 3 days. However, close monitoring of analgesic effect should be performed in order to remove the catheter as soon as the pain condition allows it. With this technique a significant reduction in the need for opioids has been observed.
In clinical studies an epidural infusion of ropivacaine hydrochloride 2 mg/ml alone or mixed with fentanyl 1-4 μg/ml has been given for postoperative pain management for up to 72 hours. The combination of ropivacaine hydrochloride and fentanyl provided improved pain relief but caused opioid side effects. The combination of ropivacaine hydrochloride and fentanyl has been investigated only for ropivacaine hydrochloride 2 mg/ml.
When prolonged peripheral nerve blocks are applied, either through continuous infusion or through repeated injections, the risks of reaching a toxic plasma concentration or inducing local neural injury must be considered. In clinical studies, femoral nerve block was established with 300 mg ropivacaine hydrochloride 7.5 mg/ml and interscalene block with 225 mg ropivacaine hydrochloride 7.5 mg/ml, respectively, before surgery. Analgesia was then maintained with ropivacaine hydrochloride 2 mg/ml. Infusion rates or intermittent injections of 10-20 mg per hour for 48 hours provided adequate analgesia and were well tolerated.
Normally there is no need to modify the dose in patients with impaired renal function when used for single dose or short-term treatment (see section 4.4. and 5.2).
Ropivacaine hydrochloride 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 (see section 4.4. and 5.2).
| Indication | Concentration mg/ml | Volume ml/kg | Dose mg/kg |
|---|---|---|---|
| Single Caudal Epidural Block | 2.0 | 1 | 2 |
| Blocks below T12, in children with a body weight up to 25 kg | |||
| Continuous epidural infusion In children with a body weight up to 25 kg | |||
| 0 up to 6 months | |||
| Bolus dosea | 2.0 | 0.5-1 | 1-2 |
| Infusion up to 72 hours | 2.0 | 0.1 ml/kg/h | 0.2 mg/kg/h |
| 6 up to 12 months | |||
| Bolus dosea | 2.0 | 0.5-1 | 1-2 |
| Infusion up to 72 hours | 2.0 | 0.2 ml/kg/h | 0.4 mg/kg/h |
| 1 to 12 years | |||
| Bolus doseb | 2.0 | 1 | 2 |
| Infusion up to 72 hours | 2.0 | 0.2 ml/kg/h | 0.4 mg/kg/h |
The dose in the table should be regarded as guidelines for use in paediatrics. Individual variations occur. 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. The volume for single caudal epidural block and the volume for epidural bolus doses should not exceed 25 ml in any patient Standard text books should be consulted for factors affecting specific block techniques and for individual patient requirements.
a Doses at the low end of the dose intervals are recommended for thoracic epidural blocks while doses in the high end are recommended for lumbar or caudal epidural blocks.
b Recommended for lumbar epidural blocks. It is good practice to reduce the bolus dose for thoracic epidural analgesia.
The proposed ropivacaine doses for peripheral block in infants and children provide guidelines for use in children without severe disease. More conservative doses and close monitoring are recommended for children with severe disease.
Single injections for peripheral nerve block (e.g. ilioinguinal nerve block, brachial plexus block) should not exceed 2,5-3,0 mg/kg.
Continuous infusion for peripheral nerve block are recommended at 0,2-0,6 mg/kg/h (0,1-0,3 ml/kg/h) up to 72 h.
The use of ropivacaine hydrochloride in premature children has not been documented.
Epidural administration by infusion.
Careful aspiration before and during injection is recommended to prevent intravascular injection. The patient’s vital functions should be observed closely during the injection. If toxic symptoms occur, the infusion should be stopped immediately.
A single caudal epidural injection of ropivacaine hydrochloride 2 mg/ml produces adequate postoperative analgesia below T12 in the majority of patients when a dose of 2 mg/kg is used in a volume of 1 ml/kg. The volume of the caudal epidural injection may be adjusted to achieve a different distribution of sensory block, as recommended in standard textbooks. In children above 4 years of age, doses up to 3 mg/kg of a concentration of ropivacaine hydrochloride 3 mg/ml have been studied. However, this concentration is associated with a higher incidence of motor block.
Fractionation of the calculated local anaesthetic dose is recommended, whatever route of administration.
In case injection of ropivacaine hydrochloride is recommended, Ropivacaine solution for injection can be used.
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 (see section 4.8. “Acute systemic toxicity”, “Central nervous system” and “Cardiovascular toxicity”).
If signs of acute systemic toxicity or total spinal block appear, infusion 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.
Shelf-life before opening: 3 years.
Shelf-life after opening: 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 and would normally not be longer than 24 hours at 2 to 8°C.
For shelf life of mixtures see section 6.6.
Do not freeze.
For storage conditions after opening the medicinal product, see section 6.3.
Ropivacaine 2 mg/ml solution for infusion.
Polypropylene bags:
10 × 100ml, 20 × 100ml, 5 × 200 ml, 10 × 200ml, 20 × 200ml, 5 × 250 ml, 10 × 250ml, 20 × 250ml, 5 × 500 ml
Not all pack sizes may be marketed.
Ropivacaine products are preservative free and are intended for single use only. Discard any unused solution.
The medicinal product should be visually inspected prior to use. The solution should only be used if it is clear, practically free from particles and if the container is undamaged.
The intact container must not be re-autoclaved.
Ropivacaine solution for infusion in polypropylene infusion bags is chemically and physically compatible with the following drugs:
| Concentration of Ropivacaine: 1-2 mg/ml | |
|---|---|
| Additive | Concentration* |
| Fentanyl citrate | 1.0-10.0 µg/ml |
| Sufentanil citrate | 0.4–4.0 µg/ml |
| Morphine sulphate | 20.0–100.0 µg/ml |
| Clonidine hydrochloride | 5.0–50 µg/ml |
* The concentration ranges stated in the table are wider than those used in clinical practice. Epidural infusions of Ropivacaine/sufentanil citrate, Ropivacaine /morphine sulphate and Ropivacaine/clonidine hydrochloride have not been evaluated in clinical studies.
The mixtures are chemically and physically stable for 30 days at 20 to 30°C. From a microbiological point of view, the mixtures should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C.
The infusion bags are equipped with an insertion port for the infusion device and an injection port for adding other pharmaceutical products into the solution. After adjunction, mix well prior to administration.
Any unused product or waste material should be disposed of in accordance with local requirements
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