Other safety alerts
|
| |
| The United Kingdom: Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Limited, Mycophenolate Mofetil 1g/5ml Oral Suspension |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that Rosemont Pharmaceuticals Limited has informed the MHRA that the Press-In-Bottle-Adaptor (PIBA) supplied with Mycophenolate Mofetil 1g / 5ml Oral Suspension (batch number: MYC23001, MYC24001, MYC24002, MYC24003, MYC24004, MYC24005, MYC24006, MYC24007, MYC24008) may cause the medicine to leak when attempting to withdraw a dose. Further to this, in rare instances, the seal on the PIBA can get damaged and small pieces of plastic may break off.
Mycophenolate mofetil is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Healthcare professionals should continue to prescribe the product, the batches listed are not being recalled. The PIBA is an aid to dispensing and the product can be administered accurately using the syringe without the PIBA.
Specific ‘Advice for patients’ is included in this alert for the safe and accurate administering the product. Please provide these instructions to patients when dispensing the product. For details please refer to the website in MHRA.
The specific instructions in the Patient Information Leaflet (PIL) for cleaning the syringe between administration of doses should continue unchanged.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-rosemont-pharmaceuticals-limited-mycophenolate-mofetil-1g-slash-5ml-oral-suspension-el-24-a-slash-59
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Dec 3, 2024
Issued at HKT 15:15
|
| |
