Posology : מינונים

4.2 Posology and method of administration
Ropivacaine B. Braun should only be used by or under the supervision of clinicians experienced in regional anaesthesia.

Adults and children above 12 years of age:
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.

Dosage recommendations for Ropivacaine B. Braun in adults and adolescents above 12 years of age

Conc. Volume         Dose      Onset   Duration mg/   ml             mg        minutes hours ml
Surgical Anaesthesia
Lumbar epidural                             150-
10.0      15-20                  10-20     4-6 administration for                          200 surgery
Acute Pain
Management
Lumbar Epidural
Administration
Bolus                2         10-20    20-40         10-15     0.5-1.5 Intermittent         2         10-15    20-30 injections (top-up)            (minimum
(e.g. labour pain              interval management)                    30 min)

Continuous infusion    2       6-10 ml/h    12-20     n/a       n/a e.g.                                        mg/h
Labour pain
Postoperative pain     2       6-14 ml/h    12-28     n/a       n/a management                                  mg/h
Thoracic Epidural
Administration
Continuous infusion    2       6-14 ml/h    12-28     n/a       n/a (postoperative pain                         mg/h management)
Field Block
(e.g. minor nerve      2       1-100        2-200     1-5       2-6 blocks and infiltration)
Peripheral nerve block
(Femoral or interscalene block)
Continuous infusion 2           5-10 ml/h 10-20       n/a       n/a or                                           mg/h intermittent injections (e.g.
postoperative management)
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 reflect the expected average dose range needed. Standard textbooks should be consulted for factors affecting specific block techniques and for individual patient requirements.
n/a = not applicable

* With regard to major nerve block, only for brachial plexus block a dose recommendation can be given. For other major nerve blocks lower doses may be required. However, there is presently no experience of specific dose recommendations for other blocks.
1) Incremental dosing should be applied, the starting dose of about 100 mg (97.5 mg = 13 ml; 105 mg = 14 ml) to be given over 3–5 minutes. Two extra doses, in total an additional 50mg, may be administered as needed.
2) The dose for a major nerve block must be adjusted according to site of administration and patient status.
Interscalene and supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anaesthetic used (see Special warnings section 4.4).


In general, surgical anaesthesia (e.g. epidural administration) requires the use of the higher concentrations and doses. The Ropivacaine B. Braun 10 mg/ml formulation is recommended for epidural anaesthesia in which a complete motor block is essential for the surgery. For analgesia (e.g. epidural administration for acute pain management) the lower concentrations and doses are recommended.

Method of administration
Careful aspiration before and during injection is recommended to prevent intravascular injection. When a large dose is to be injected, a test dose of a short acting anaesthetic (e.g.3-5 ml lidocaine ) is recommended. An inadvertent intravascular injection may be recognized 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- 50mg/min while closely observing the patient’s vital functions and maintaining verbal contact.
If toxic symptoms occur, the injection should be stopped immediately.
In epidural block for surgery, single doses of up to 250 mg Ropivacaine have been used and well tolerated.
In brachial plexus block a single dose of 300 mg has been used in a limited number of patients and was well tolerated.

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 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 unless preoperatively instituted, an epidural block is induced via an epidural catheter. Analgesia is maintained with Ropivacaine B. Braun 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 B. Braun 2 mg/ml alone or mixed with fentanyl 1-4 mcg/ml has been given for postoperative pain management for up to 72 hours.

The combination of Ropivacaine B. Braun and fentanyl provided improved pain relief but caused opioid side effects. The combination of Ropivacaine B.
Braun and fentanyl has been investigated only for Ropivacaine B. Braun 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.
Infusion rates or intermittent injections of 10–20 mg per hour for 48 hours provided adequate analgesia and were well tolerated.
Concentrations above 7.5 mg/ml Ropivacaine B. Braun have not been documented for Caesarean section.

Until further experience has been gained, Ropivacaine B. Braun cannot be recommended for use in children below the age of 12 years.