Provive and Sandoz propofol 1% emulsion for injection - all sizes and all batches

Health professionals, hospitals and health facilities are advised that batches of a widely used intravenous anaesthetic drug, propofol, may include some vials that have been contaminated with the bacteria Ralstonia pickettii. To address this issue, AFT Pharmaceuticals, in consultation with the TGA, has quarantined two batches of Provive MCT-LCT 1% (propofol 1%) emulsion for injection in 20 ml vials. This action is being taken due to potential contamination with the bacteria Ralstonia pickettii.

The affected batch numbers are:

• A030906 (expiry date 08/15)
• A030907 (expiry date 08/15).

Additionally, health professionals are advised to, where possible, avoid use of all sizes and all batches of Provive and Sandoz propofol 1% products pending further investigation into this issue:

ARTG	ARTG Label
118940	Claris Lifesciences Australia Pty Ltd PROVIVE 1% propofol 1000mg/100mL emulsion for injection vial
118938	Claris Lifesciences Australia Pty Ltd PROVIVE 1% propofol 200mg/20mL emulsion for injection vial
162319	PROVIVE MCT-LCT 1% propofol 500mg/50mL emulsion for injection vial
118939	Claris Lifesciences Australia Pty Ltd PROVIVE 1% propofol 500mg/50mL emulsion for injection vial
162320	PROVIVE MCT-LCT 1% propofol 1000mg/100mL emulsion for injection vial
162318	PROVIVE MCT-LCT 1% propofol 200mg/20mL emulsion for injection vial
148870	PROPOFOL SANDOZ propofol 200mg/20mL emulsion for injection vial
148872	PROPOFOL SANDOZ propofol 1000mg/100mL emulsion for injection vial
148871	PROPOFOL SANDOZ propofol 500mg/50mL emulsion for injection vial

Hospitals should seek alternatives to these brands and only use Provive and Sandoz propofol 1% products if there are no suitable alternatives and only if the benefits outweigh the risks to the patient.

Propofol 1% is used as a short-acting general anaesthetic in adults, and children aged three years or older.

There have been reports of patients having developed sepsis after Provive MCT-LCT 1% was administered to them while being treated in hospitals.

Ralstonia pickettii are Gram-negative bacteria. It may take several days for a blood culture to become positive and may be difficult for a laboratory to identify. Possible initial identifications include Stenotrophomonas, Burkholderia and Pseudomonas species of bacteria.

Information for consumers

This medicine is only used in hospitals and certain health facilities.

Hospitals and health facilities have been contacted and provided further information about this issue, including details of the quarantine process.

If you have any questions or concerns about this issue, talk to your health professional.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.