Information about the temporary suspension of distribution and use of three batches of Manit 10%
12.09.2013
The Agency for Medicinal Products and Medical devices has carried out a special quality control of the baches 2004032, 2004072 and 2050102 of Manit 10%.
We remind that on the 10th April 2013, HALMED informed about the initiation of the suspension of distribution and use of the batches 2004032, 2004072 and 2050102 of Manit 10%, upon a report from a healthcare professional to a suspected adverse reaction to trombolflebitis on the application site of manitol 10% in six patients.
The special quality control confirms that the tested samples of Manit 10% of the three batches correspond to adopted quality requirements regarding the tested parameters. With regard to the aforementioned test results, the temporary suspension and use of batches 2004032, 2004072 and 2050102 of Manit 10% is being revoked and the existing stocks may be again distributed and used.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
