Manufacturer Sanofi has imported Clexane 40mg/0.4ml solution for pre-filled syringes from Italy, to cope with a UK-wide shortage caused by a “quality issue” with a particular UK batch, the Pharmaceutical Services Negotiating Committee (PSNC) said yesterday (January 23).
The “most important” difference between the Italian and UK batches of Clexane is the needle guard device, which patients and healthcare professionals “will need to be trained” to use, PSNC said.
The Italian needle protective sleeve is activated by the user, while the UK needle protective sleeve is auto-activated, PSNC said.
“To deploy the needle shield on the Italian syringes, users will need to firmly push the plunger after completing the injection,” it added. “The user will hear an audible click to confirm the activation of the protective sleeve and the sleeve will cover the needle.”
The text on the imported packaging will be in Italian, but the boxes will contain a patient information leaflet in English, PSNC explained.
Pharmacies and GPs should “work closely”
The Department of Health and Social Care (DH) has advised pharmacies to review patients on Clexane 40mg to determine their stock levels, PSNC said.
The next UK batch of Clexane should be available from February 18, it said.
Pharmacies and GP practices should “work closely to discuss local management options”, the negotiator added.