其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Sandoz Limited, Zinacef powder for solution for injection or infusion vials (all strengths, including stock in GSK livery) (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Sandoz Limited 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, Sandoz Limited considers this to pose a potential for medication errors.
Sandoz Limited would like to make clear that reconstitution with aqueous solutions containing up to 1% lidocaine hydrochloride is intended only for intramuscular (IM) use.
This problem impacts Zinacef batches marketed by the current Marketing Authorisation Holder, Sandoz Limited, and the former Marketing Authorisation Holder GlaxoSmithKline Ltd. The affected products are:
- Zinacef 250mg powder for solution for injection or infusion vials (batch number: 23K01810, 23K00020, 23K00021, 2004E2, 2003E2)
- Zinacef 750mg powder for solution for injection or infusion vials (batch number: 22K01918, 22K01919, 23K00019, 22K00713, 22K00604, 2002E2)
- Zinacef 1.5g powder for solution for injection or infusion vials (batch number: 23K02206, 2002E2)
GSK livery
- Zinacef 250mg powder for solution for injection or infusion vials (batch number: 2001E2, 2005E1, 2002E1, 2004E1, 2003E1)
- Zinacef 750mg powder for solution for injection or infusion vials (batch number: 2008E1, 2001E2, 2009E1, 2005E1, 2002E1, 2003E1, 2004E1, 2006E1, 2001E1)
- Zinacef 1.5g powder for solution for injection or infusion vials (batch number: 2003E1, 2005E1, 2006E1, 2007E1, 2009E1, 2010E1, 2011E1, 2013E1, 2014E1)
Healthcare professionals are advised that 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/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-slash-38
In Hong Kong, Zinacef For Inj 250mg (HK-07013), Zinacef For Inj 750mg (HK-07014) and Zinacef For Inj 1.5g (HK-07015) are pharmaceutical products registered by Sandoz Hong Kong Limited (Sandoz). All products are prescription-only medicines. In light of the above MHRA’s announcement, the Department of Health (DH) contacted Sandoz to assess the impact on the Zinacef products marketed in Hong Kong. As confirmed with Sandoz, the product insert of the local Zinacef products will be updated accordingly.
Ends/Tuesday, Oct 24, 2023
Issued at HKT 15:30
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