OECDReferencia EN/AU/PS1096550
NovoMix 30 Penfill
Información oficial organizada para facilitar su consulta. La publicación de la fuente conserva la autoridad.
Identificación
Identificación del producto
- Producto
- NovoMix 30 Penfill
- Identificadores oficiales
- EAN: 9324627001303
Información oficial
Riesgo y medidas
- Riesgo o peligro
- 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.
- Recomendaciones
- 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.
Información oficial
Operadores económicos
- Fabricante
- Novo Nordisk Pharmaceuticals Pty Ltd
Territorio
Geografía
- Origen
- Brazil
- Distribución
- Retirada en Australia
- País de retirada
- Australia
Procedencia y contexto
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