OECDReference EN/AU/PS1096550
NovoMix 30 Penfill
Official information organised for easier consultation. The source publication remains authoritative.
Identification
Product identification
- Product
- NovoMix 30 Penfill
- Official identifiers
- EAN: 9324627001303
Official information
Risk and measures
- Risk or hazard
- 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.’ 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.
- Recommendations
- 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.
Official information
Economic operators
- Manufacturer
- Novo Nordisk Pharmaceuticals Pty Ltd
Territory
Geography
- Origin
- Brazil
- Distribution
- Retirada en Australia
- Country of recall
- Australia
Provenance and context
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