Description of change

SmPC was updated to reflect approval of Type IB Label alignment for Chirocaine 7.5 mg/ml solution for injection/concentrate for solution for infusion.

The following is summary of the changes:

The Summary of Product Characteristics title has been added in line with QRD

4.1     Therapeutic indications

Minor editorial updates.

4.2     Posology and method of administration

Minor editorial updates.

4.4     Special warnings and precautions for use

Minor editorial updates.

4.5     Interaction with other medicinal products and other forms of interaction

Minor editorial updates.

4.6     Fertility, pregnancy and lactation

Minor editorial update.

4.8     Undesirable effects

Minor editorial updates.

10.       Date of Revision of Text

Update to July 2018.

Section 7: Marketing Holder Authorisation:

Update to MAH address

 To update Section 4.4 of the SmPC to include adverse drug reaction of chondrolysis in patients receiving post-operative intra-articular continuous infusion of local anaesthetics.

Section 4.1 & Section 4.2

No data are available in paediatric population < 6 months of age.

Section 4.8

Information on how to report an AE in Ireland.

Marketing Authorisation holder changed from

Abbott Laboratories Ireland Ltd

4051 Kingswood Drive

Citywest Business Campus

Dublin 24

to

AbbVie Limited

Block B

Liffey Valley Office Campus

Quarryvale

Co.Dublin

Section 8

PA number changed from  PA 38/71/7 to PA 1824/3/3

Section 4.2 (Posology and method of administration)
The following statement has been added:

There is limited safety experience with levobupivacaine therapy for periods exceeding 24 hours. In order to minimise the risk for severe neurological complications, the patient and the duration of administration of levbupivacaine should be closely monitored (see Section 4.4).

Section 4.4 (Special warnings and precautions for use)
The following sub section has been added:

Epidural Analgesia

There have been postmarketing reports of cauda equina syndrome and events indicative of neurotoxicity (see Section 4.8) temporally associated with the use of levobupivacaine for 24 hours or more for epidural analgesia. These events were more severe and in some cases led to permanent sequelae when levobupivacaine was administered for more than 24 hours. Therefore,  infusion of levobupivacaine for a period exceeding 24 hours should be considered carefully and only be used when benefit to the patient outweighs the risk.

It is essential that aspiration for blood or cerebrospinal fluid (where applicable) be done prior to injecting any local anesthetic, both before the original dose and all subsequent doses, to avoid intravascular or intrathecal injection. However, a negative aspiration does not ensure against intravascular or intrathecal injection. Levobupivacaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics, since the toxic effects of these drugs are additive.

Section 4.8

The paragraph:

Rare reports have been received of cauda equina syndrome or signs and symptoms of potential injury to the base of the spinal cord or spinal nerve roots (including lower extremity weakness or paralysis, loss of bowel control and/or bladder control and priapism) associated with bupivacaine or levobupivacaine therapy.

has been changed to:

Reports have been received of cauda equina syndrome or signs and symptoms of potential injury to the base of the spinal cord or spinal nerve roots (including lower extremity paraesthesia, weakness or paralysis, loss of bowel control and/or bladder control and priapism) associated with levobupivacaine administration. These events were more severe and in some cases did not resolve when levobupivacaine was administered for more than 24 hours (see Section 4.4).

The sentence:

"There have been rare reports of transient Horner's syndrome---" has been changed to "There have been reports of transient Horner's syndrome---"

Section 4.1 (Therapeutic Indications)
Labour analgesia has been deleted


Section 4.2 (Posology and method of administration)

"For caesarean section, higher concentrations than the 5.0 mg/ml solution should not be used (see section 4.3)."

has been amended to 
 

For obstetric procedure (including caesarean section), higher concentrations than the 5.0 mg/ml solution should not be used (see section 4.3).

The following statement has been added under "Children".
"The maximum dosage should be adjusted according to the size, body constitution and physical status of the patient/child."


Update has been made to the dosing table to better clarify the volume of the product for the 2.5 mg/ml concentration required to administer a dose of 1.25 mg/kg/side and the volume of the product for the 5.0 mg/ml concentration required to administer a dose of 1.25 mg/kg/side