Consumers and health professionals are advised that Actelion Pharmaceuticals Australia, in consultation with the TGA, is recalling two batches of its Veletri consumables kit.
Veletri consumables kits are used to administer the medicine epoprostenol sodium (with the trade name Veletri), which can be prescribed to treat some types of pulmonary arterial hypertension. Before this medicine is used, it must be dissolved in sterile water for injection or sodium chloride 0.9% solution for injection. Veletri consumables kits can be used in health facilities or, after treatment is established, in a patient’s home.
Veletri consumables kits with batch numbers 0309757 or 0309991 include B. Braun water for injections 100 mL from lot 14217404. It has been identified that B. Braun water for injections from this lot may leak due to cracks in the neck of the bottle, which could result in bacterial contamination.
If the B. Braun water for injections 100 mL used to administer Veletri is contaminated with bacteria, there is a low risk of infection to the patient. As of 9 February 2016, there have been no reports of infection as a result of this issue in Australia or overseas.
Actelion Pharmaceuticals Australia is replacing all potentially affected Veletri consumables kits.
In the meantime, patients should not stop taking Veletri. The impact of interrupting treatment is likely to outweigh the low risk of infection from bacterial contamination.
If no alternative water for injections product is available, patients should carefully inspect bottles of B. Braun water for injections 100 mL from lot 14217404 before use and discard any bottle that shows signs of potential cracking.
Information for consumers
If you or someone you care for is taking Veletri, check their Veletri consumables kit to see if it comes from batch number 0309757 or 0309991.
If so, try to obtain an alternative water for injections product. If one is not available, do not stop taking Veletri. You can continue to use B. Braun water for injections 100 mL from lot 14217404 if you carefully inspect the bottle beforehand.
Check that the bottle appears to be full. Tip the bottle upside down and gently squeeze it to check for any leaks from the neck. Ensure the contents appear clear and colourless. If any leaks are observed, or if the water appears cloudy, discard the bottle and use a different one.
The risk of infection as a result of bacterial contamination of the B. Braun water for injections 100 mL from lot 14217404 included in your Veletri consumables kit is low. The potential impact of interrupting treatment with Veletri outweighs the risks associated with this issue.
If you have already used B. Braun water for injections 100 mL from lot 14217404 and did not notice any issues with the water or experienced any unusual symptoms after use, the risk of an infection is low.
If you have reconstituted cassettes in your fridge that contain B. Braun water for injections from the affected batch, you are advised to make a fresh lot of cassettes using an alternative water for injections product. If one is not available, and you did not notice any leakage or other signs of potential problems when you made up your cassettes, you can continue to use them as usual.
Once replacement Veletri consumables kits are received, you should immediately stop using any old kits that contain B. Braun water for injections 100 mL from lot 14217404.
If you have any questions or concerns, or feel unwell, contact your health professional. Alternatively, you can call Actelion Pharmaceuticals Australia on 1300 116 441.
Information for health professionals
Actelion Pharmaceuticals Australia has written to health professionals and hospitals providing further information about this issue, including details of the recall procedure.
If you have any unused Veletri consumables kits in stock, check to see if they are from the affected batch. Affected products will be replaced as quickly as possible.
If you are treating patients who use Veletri consumables kits, advise them of this issue. Reassure them that the risk of them getting an infection as a result of bacterial contamination of the B. Braun water for injections 100 mL from lot 14217404 is very low and that, as of 9 February 2016, no reports of this adverse event have been reported in Australia or overseas.
Instruct patients to continue taking Veletri as prescribed. Advise them of the instructions provided above in the 'Information for consumers' section.
Until replacement kits can be provided, it is recommended that an alternative unaffected water for injections product be used. If one is not available, you should carefully check each bottle before use. Check that the bottle appears to be full. Tip the bottle upside down and gently squeeze it to check for any leaks from the neck. Ensure the contents appear clear and colourless. If any leaks are observed, or if the water appears cloudy, discard the bottle and use a different one.
If you have any questions or concerns, contact Actelion Pharmaceuticals Australia on 1300 116 441.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines, vaccines or medical devices. 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, vaccine or medical device.