January 5th, 2006

Additional packaging safety innovations for Octagam®


Octapharma USA Inc. announced today the introduction of several new packaging enhancements for Octagam® (immune globulin intravenous [human] 5%). These country-specific changes were developed to meet the specific needs and challenges of the US market.

Octagam 5g (100ml) and 10g (200ml) presentations will now be packaged in new plasticized cartons.  These offer the advantage of improved strength and durability during the complex transportation and handling from Vienna to, and within, the United States.

Furthermore, in response to increasing concerns in the US about drug-counterfeiting and product tampering, Octapharma has introduced additional measures to increase the tamper-proof attributes of Octagam packaging.

With immediate effect all batches of Octagam 5% shipped to the USA will be equipped with tamper-evident adhesive tape on both the top and bottom end of every individual carton.

	Picture 1

On the closed carton, the blue area represents the area where the logo will appear later. In reality, this area is white, when the label is closed. (picture 1).

	Picture 2

After the first opening of the carton the Octapharma logo appears in blue (picture 2).

	Picture 3

If, re-closure of the carton is attempted the safety label displays the Octapharma logo in white (picture 3).








This existing tamper-evident safety measures will be maintained, i.e. each vial of Octagam is supplied with an integral flip top that cannot be reattached after opening and a unique ink-jet number printed on the cap which codes the batch ID*.

“We are confident that taken together, these measures will improve the safety and integrity of Octagam by increasing the detection of unauthorized opening” said Judi Miller, Medical Affairs Director, Octapharma USA .

Customers are advised to carefully check each vial to ensure its integrity before use. If tampering is suspected, the product should not be opened or used and the incident should be reported as soon as possible to Octapharma by calling us toll free at 1-866-766-4860.

*The new MultiSeal labels are manufactured by Schreiner ProSecure, in Germany.