NovoMix 30 Penfill
(NovoMix 30 Penfill 3mL 30% soluble insulin aspart (rys) and 70% insulin aspart (rys) crystallised with protamine 300U/3mL injection cartridge)
What are the defects?
The instructions inside the product has incorrect labelling:
- The customer medicine information has incomplete description of the active ingredient and its appearance.
- The pack insert incorrectly states: ‘Do not keep the NovoMix® 30 Penfill® that you are using, or that you are carrying as a spare, with you.
The storage conditions are correctly stated on the product carton. The correct statement reads:
- ‘You can carry the NovoMix® 30 Penfill® that you are using, or that you are carrying as a spare, with you. You can keep it at room temperature (not above 30°C) or in a refrigerator (2°C - 8°C) for up to 4 weeks.’
What are the hazards?
The effects of exposure to protamine sulfate to users who are allergic to this ingredient or to fish, may result in a severe to life threatening allergic reaction.
What should consumers do?
Consumers should follow the instructions on the carton which indicate to keep the NovoMix® 30 Penfill® they are using, or carrying as a spare, either below 30°C or in a refrigerator (2°C - 8°C).
Consumers can obtain a current Consumer Medicine Information leaflet from a pharmacist or visit the TGA website at https://www.ebs.tga.gov.au/
For further information, contact NovoNordisk Customer Service by phone on 1800 668 626.
Traders who sold this product
Pharmacies and distributors