03-12-2017| Buccolam (Midazolam) : Important Safety Information

'03-12-2017| Buccolam (Midazolam) : Important Safety Information' image

Shire Services BVBA, manufacturers of Buccal Midazolam, have informed the Health Products Regulatory Authority in Ireland (HPRA) of a possible defect with the Buccolam (Midazolam) prefilled plastic syringes.

In a small number of cases the translucent tip-cap has remained on the syringe tip when pulling the red cap off. If the tip cap stays on the syringe tip it will prevent the Buccolam medicine from entering the area between the cheek and gum as intended. If this happens the tip cap will need to be removed manually to stop it from falling into the mouth area when the syringe is pressed.

When giving Buccolam from a prefilled syringe check to see that the tip cap has come off before use and if it hasn't then use your fingers to remove it.

Shire BVBA is currently addressing this defect.