Class 4 Medicines Defect Information: Sandoz Limited, Zinacef powder for solution for injection or infusion vials (all strengths, including stock in GSK livery), EL (23)A/38

Sandoz has detected that information on the diluents in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) of cefuroxime contain incorrect information.

MDR Number: MDR 038-09/23

Company name: Sandoz Limited + GlaxoSmithKline

Product descriptions:

Zinacef 250mg powder for solution for injection or infusion vials (Sandoz), PL 48870/0039 Snomed code 4740211000001106

 

Zinacef 750mg powder for solution for injection or infusion vials (Sandoz), PL 48870/0040 Snomed code 3939311000001103

 

Zinacef 1.5g powder for solution for injection or infusion vials (Sandoz), PL 48870/0041 Snomed code 4530311000001103

 

Zinacef 1.5g powder for solution for injection or infusion vials (GSK), PL 00004/0263 Snomed code 4530311000001103

 

Zinacef 250mg powder for solution for injection or infusion vials (GSK), PL 00004/0263 Snomed code 4740211000001106

 

Zinacef 750mg powder for solution for injection or infusion vials (GSK), PL 00004/0263 Snomed code 3939311000001103

Brief description of problem:

Sandoz, the Marketing Authorisation Holder (MAH), has detected that information on the diluents in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) of cefuroxime offer possibility for both intramuscular (IM) and intravenous (IV) administration. The PIL and SmPC state that cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride. However, dilution with lidocaine is intended only for intramuscular (IM) use. As this is not explicitly mentioned, the MAH considers this to pose a potential for medication errors.

The current instructions within the PIL and SmPC, and the corrected instructions (for future PILs and SmPCs) are detailed below:

The MAH would like to make clear that reconstitution with aqueous solutions containing up to 1% lidocaine hydrochloride is intended only for intramuscular (IM) use.

Note: This problem impacts Zinacef batches marketed by the current Marketing Authorisation Holder, Sandoz Ltd, and the former Marketing Authorisation Holder GlaxoSmithKline Ltd.

Advice to Healthcare Professionals:

There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to ensure they aware that Zinacef products reconstituted with aqueous solutions containing up to 1% lidocaine hydrochloride are intended only for intramuscular (IM) use.

If lidocaine is injected intravenously (IV), it may cause cerebral effects such as confusion, changes in vision, numbness, tingling, and vomiting. It can also cause low blood pressure and an irregular heart rate, thereby posing a risk to patients.

Advice to Patients:

No further action is required by patients, the product is administered by healthcare professionals directly. If you have concerns about a medicine you may be using, please contact your healthcare professional. Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

For more information, medical information queries: sandozgb@EU.propharmagroup.com, Telephone: +44 1276 698 101.

For stock control queries: sales.sandoz-gb@sandoz.com, Telephone: +44 1276 698607

To access the full recall: Class 4 Medicines Defect Information: Sandoz Limited, Zinacef powder for solution for injection or infusion vials (all strengths, including stock in GSK livery), EL (23)A/38