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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

Medicines Healthcare Products Regulatory Agency

October 23
12:57 2023

MDR number

MDR 038-09/23

Company name

Sandoz Limited

Zinacef 250mg powder for solution for injection or infusion vials, PL 48870/0039

SNOMED Code

4740211000001106

Batch No Expiry Date Pack Size First Distributed
23K01810 11-2025 1 07/06/2023
23K00020 09-2025 1 30/03/2023
23K00021 09-2025 1 30/03/2023
2004E2 03-2025 1 31/10/2022
2003E2 05-2025 1 31/10/2022

Zinacef 750mg powder for solution for injection or infusion vials, PL 48870/0040

SNOMED Code

3939311000001103

Batch No Expiry Date Pack Size First Distributed
22K01918 08-2025 1 02/06/2023
22K01919 09-2025 1 02/06/2023
23K00019 09-2025 1 02/06/2023
22K00713 08-2025 1 22/12/2022
22K00604 08-2025 1 22/12/2022
2002E2 06-2025 1 07/10/2022

Zinacef 1.5g powder for solution for injection or infusion vials, PL 48870/0041

SNOMED Code

4530311000001103

Batch No Expiry Date Pack Size First Distributed
23K02206 04-2026 1 27/06/2023
2002E2 04-2025 1 31/05/2023

Active Pharmaceutical Ingredient: Cefuroxime Sodium

GlaxoSmithKline Ltd

Zinacef 1.5g powder for solution for injection or infusion vials, PL 00004/0263

SNOMED Code

4530311000001103

Batch No Expiry Date Pack Size First Distributed
2003E1 02-2024 1 13/04/2021
2005E1 02-2024 1 07/06/2021
2006E1 04-2024 1 06/07/2021
2007E1 04-2024 1 04/10/2021
2009E1 07-2024 1 04/10/2021
2010E1 07-2024 1 06/12/2021
2011E1 10-2024 1 06/12/2021
2013E1 10-2024 1 13/12/2021
2014E1 10-2024 1 07/02/2022

Zinacef 250mg powder for solution for injection or infusion vials, PL 00004/0263

SNOMED Code

4740211000001106

Batch No Expiry Date Pack Size First Distributed
2001E2 10-2024 1 29/01/2022
2005E1 09-2024 1 03/03/2022
2002E1 12-2023 1 05/03/2021
2004E1 07-2024 1 07/11/2021
2003E1 07-2024 1 11/11/2021

Zinacef 750mg powder for solution for injection or infusion vials, PL 00004/0263

SNOMED Code

3939311000001103

Batch No Expiry Date Pack Size First Distributed
2008E1 07-2024 1 07/11/2021
2001E2 12-2024 1 03/03/2022
2009E1 10-2024 1 03/03/2022
2005E1 05-2024 1 28/07/2021
2002E1 01-2024 1 02/04/2021
2003E1 03-2024 1 02/06/2021
2004E1 04-2024 1 17/06/2021
2006E1 07-2024 1 22/10/2021
2001E1 12-2023 1 10/02/2023

Active Pharmaceutical Ingredient: Cefuroxime Sodium

Brief description of the 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:

Current instructions within PIL and SmPC Corrected instructions (changes underlined)
Instructions for reconstitution

Compatibility
1.5 g cefuroxime sodium constituted with 15 mL Water for Injection may be added to metronidazole injection (500 mg/100 mL).
1.5 g cefuroxime sodium is compatible with azlocillin 1 g (in 15 mL) or 5 g (in 50 mL).
Cefuroxime sodium (5 mg/mL) in 5% w/v or 10% w/v xylitol injection may be used. Cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.
Instructions for reconstitution

Compatibility
1.5 g cefuroxime sodium constituted with 15 mL Water for Injection may be added to metronidazole injection (500 mg/100 mL).
1.5 g cefuroxime sodium is compatible with azlocillin 1 g (in 15 mL) or 5 g (in 50 mL).
Cefuroxime sodium (5 mg/mL) in 5% w/v or 10% w/v xylitol injection may be used for intravenous use only..

Zinacef 250 mg, 750 and 1.5 g powder for solution for injection or infusion (intramuscular use only).
Cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride for intramuscular use.

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 for 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.

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