Dear Healthcare Professional Letter on the new/modified storage conditions of Octanate 1000 IU powder and solvent for solution for injection and Octanate 500 IU powder and solvent for solution for injection

16.09.2014

Jana Pharm d.o.o. has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals on the new/modified storage conditions for Octanate.

Summary

Taking account that the new package leaflet indicating the new storage conditions at 2 to 9°C cannot be provided, in order to ensure a continuous supply chain, HALMED has exceptionally and temporarily allowed the placing of the product on the market containing the previous package leaflet with previously authorised storage conditions at 25°C that are not valid any more. Batches A34A1203, B345A1206 and B417B1205 of Octanate 500 IU and batches B405C1202 and B410A1201 of Octanate 1000 IU are affected. These batches will be placed on the Croatian market in the middle of September 2014 and it is estimated that they will run out by the end of 2014.

The current package leaflet should be downloaded from the HALMED’s webpages (copies will be provided by the marketing authorisation holder) and patients should be advised of the new storage conditions on the temperature from 2 to 8°C, whenever a package of the medicinal product is dispensed.

Previous batches should be stored according to the attached storage conditions (up to 25°C). Batches labelled according to the current marketing authorisation , with correct storage conditions will be released by the end of November 2014.

Information to healthcare professionals

After the preparation of the solution for injection, the solution in the syringe should be clear or slightly opalescent. Turbid or sediment containing solutions may not be injected.
Healthcare professionals should advise patients to report adverse reactions if they occur to their doctor
The complete information on Octanate is available in the Summary of Product Charactersistics, intended for healthcare professionals and in the package leaflet , intended for patients. These documents are accessible on the HALMED webpages in the Medicines/ Medicines Database section, or here.

HALMED has not received any quality defect or suspected adverse reaction to Octanate that would be related to incorrect product storage. HALMED will continue to monitor from the close the safe use of this medicine and will make publically available any new information.

Here you may view the Dear Healthcare Professional Letter.

We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. 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 their doctor or pharmacist about the continuation of their therapy.