Propofol: Provive and Sandoz propofol 1% emulsion for injection - all sizes and all batches, update 1
|7 July 2014||Update 3: Provive and Sandoz propofol 1% emulsion for injection - all sizes and all batches|
|30 May 2014||Update 2: Provive and Sandoz propofol 1% emulsion for injection - all sizes and all batches|
This updates the statement published on 2 May 2014 to include details of the TGA's ongoing investigations into this issue.
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.
There have been reports of patients having developed sepsis following administration of 1% propofol injection.
In consultation with the TGA, the Australian distributor of Provive MCT-LCT 1% (propofol 1%) emulsion for injection in 20 ml vials (ARTG 162318), AFT Pharmaceuticals, has quarantined two batches due to potential contamination with Ralstonia pickettii. The affected batch numbers are:
- A030906 (expiry date 08/15)
- A030907 (expiry date 08/15).
At this time, no batches of any of the drugs listed below are subject to a recall.
As a precautionary measure, health professionals are advised, where possible, to avoid use of all sizes and all batches of the AFT-distributed Provive and Sandoz Propofol 1% products as listed below pending further investigation into this issue:
|118940||Claris Lifesciences Australia Pty Ltd PROVIVE 1% propofol 1000mg/100mL emulsion for injection vial (distributed by AFT)|
|118938||Claris Lifesciences Australia Pty Ltd PROVIVE 1% propofol 200mg/20mL emulsion for injection vial (distributed by AFT)|
|162319||PROVIVE MCT-LCT 1% propofol 500mg/50mL emulsion for injection vial (distributed by AFT)|
|118939||Claris Lifesciences Australia Pty Ltd PROVIVE 1% propofol 500mg/50mL emulsion for injection vial (distributed by AFT)|
|162320||PROVIVE MCT-LCT 1% propofol 1000mg/100mL emulsion for injection vial (distributed by AFT)|
|162318||PROVIVE MCT-LCT 1% propofol 200mg/20mL emulsion for injection vial (distributed by AFT)|
|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 consider seeking alternative sources of propofol 1% to the drugs listed above. Where there are no suitable alternatives, health professionals should satisfy themselves that the benefits outweigh the risks to the patient.
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.
The TGA is working with State and Territory health departments to gather further information regarding the reported cases of sepsis and to identify the specific organism(s) suspected of causing the infection.
In particular, the TGA is investigating the strength of the evidence linking these propofol products with the reported cases of sepsis.
As part of these investigations, the TGA is testing samples of the affected batches for microbial quality. This testing includes performing Sterility and Bacterial Endotoxin tests on the products.
Results from the sterility testing will not be available for 2-3 weeks due to the prolonged incubation period for this test and the nature of the product.
The Bacterial Endotoxin test is a quicker test, but is limited in that it only detects a component of some bacterial cells. Preliminary results from this test to date do not indicate the presence of bacterial endotoxin.
The TGA is also carefully examining the manufacturing site data to identify relevant information.
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.