HPS Pharmacies wish to give notice that Merck Sharp & Dohme (Australia) are experiencing a supply interruption for OncoTICE® vials as follows:
Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain) 5 hundred million CFU
This supply interruption is due to an unexpected increase in demand. Normal supplies are expected to resume in late December 2019. While wholesale stocks are limited, HPS Pharmacies has been able to secure a limited supply based on our historical monthly usage.
BCG-medac, an internationally registered brand of BCG vials, has also been approved for supply under Section 19A of the Therapeutic Goods Act 1989. This product is derived from a different substrain of Mycobacterium bovis BCG. The following table provides a comparison of the two products. Please refer to the BCG-medac package insert provided with the product or the Summary of Product Characteristics for further details.
|Comparison||OncoTICE®||BCG – medac
|Contents per vial||2-8×108 colony forming units BCG bacteria||2×108 to 3×109 viable units BCG bacteria|
|Substrain||Tice substrain||RIVM substrain|
|Accessories||Closed system for reconstitution is not provided with the product||Complete closed system with a connecting piece and a catheter adaptor for reconstitution and handling is provided with the product|
|Administration recommendations||One vial per bladder instillation. Reconstitute with 50mL saline||One vial per bladder instillation.
Reconstitute with 50mL saline
Please note that Section 19A alternatives are subject to a longer lead time and different pricing as they must be sourced internationally.
Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.
Should you require further information regarding this matter, please contact Merck Sharp & Dohme (Australia) on (02) 8988 8000or your pharmacist at HPS Pharmacies.