madman
Super Moderator
Class 4 Medicines Defect Information: Kyowa Kirin Limited, Tostran (Testosterone, 2% gel), EL (23)A/33
Kyowa Kirin Limited has notified MHRA that the priming instructions in the current PIL for Tostran 2% gel require updating.
Brief description of the problem
Kyowa Kirin Limited has notified MHRA that the priming instructions in the current PIL for Tostran 2% gel require updating.
Following a manufacturing change to the Tostran 2% gel dosage pump/dispenser system, the manufacturer has observed that the priming instruction requires changing. Data from the end of shelf life in-use testing has shown that the number of actuations required to prime the device to achieve correct dosing increases over time. This means that more pumps to prime the device being using it for the first time are now required. If these instructions are not followed then a less accurate first dose may be delivered. The Patient Information Leaflet and Summary Product Information will be updated to include these the new priming instructions, subject to approval by MHRA.
