Class 4 medicines defect information – Caution in Use – additional information following Drug Alerts EL(12)A/08 (issued on 28 February 2012), EL(12)A/10 (issued on 6 March 2012) and EL(12)A/16 (issued on 24 April 2012) — for distribution to hospitals, clinics, wholesalers, GPs and community pharmacists.
Ref: EL(12)A/26
Epistatus, midazolam 10mg/1ml buccal liquid x 5ml (M11) – unlicensed medicine made under manufacturers special licence MS 123.
(manufactured by Special Products)
Special products has made a final change to the syringe that comes with Epistatus, midazolam 10mg/1ml buccal liquid (midazolam) so that it does not contain a luer tip. This was corresponded in Drug Alert EL(12)A/16.
The modifications that have been made to the Epistatus packs include removal of the luer tip from the syringe and a new bottle adaptor that is compatible with the syringe without a luer tip.
The syringe is graduated to 1.0ml with a plunger stop at the 1.0ml position.
Epistatus packs with the new syringe and dosing adaptor will be identifiable as they have yellow and black flashing on the carton and states “This pack contains 1ml syringes without luer tip”.
This is expected to be the final change to the product.
Epistatus packs that contain syringes with a luer tip as mentioned in Drug Alerts EL(12)A/08, EL(12)A/10 and EL(12)A/16 will remain in the supply chain until all stock is exhausted.
All patients need to be informed that they should use the syringe graduations and not rely on the plunger stop. This applies to both the old packs and new packs as it is considered good clinical practice.
For medical information enquiries, contact Special Products medical information on 01932 690325.
