Class 4 defect information: Caspofungin 70mg powder for concentrate for solution for infusion (MDR 11-09/18)
Cadiasun Pharma GmBH has informed us that there is an error on the patient information leaflet for Caspofungin 70mg powder for concentrate for solution for infusion.
Product information
MDR number
MDR 11-09/18
Company name
Cadiasun Pharma GmBH
Product description
Caspofungin 70mg powder for concentrate for solution for infusion
PL 42069/0003
- Batch number: 180524AD
- Expiry date: April 2020
- Pack size: 1x vial
- First distributed: 19 July 2018
- Batch number: 180530AD
- Expiry date: April 2020
- Pack size: 1x vial
- First distributed: n/a
Brief description of the problem
The error is on the portion of the leaflet which is intended for Healthcare Professionals, in the sections providing instructions for preparation of both 70mg/m2 and 50mg/m2 infusion for paediatric patients > 3 months of age. In the incorrect version of the leaflet, the final concentration of the solution is given as 5.2mg/ml for both dilutions.
The correct final concentration is 7.2mg/ml.
In addition to the error on the Patient Information Leaflet, there is also an error on the Summary of Product Characteristics for the product. The heading for preparation of the 70mg/m2 infusion for paediatric patients > 3 months and the heading for preparation of the 50mg/m2 infusion for paediatric patients > 3 months incorrectly state in brackets ‘using a 50-mg vial’. The headings should read as follows:
‘Preparation of the 70 mg/m2 infusion for paediatric patients > 3months of age (using a 70-mg vial)’
‘Preparation of the 50 mg/m2 infusion for paediatric patients > 3months of age (using a 70-mg vial)’
Steps have already been taken to correct the errors on both the patient information leaflet and the Summary of Product Characteristics.
Please note, the patient information leaflet and Summary of Product Characteristics for the 50mg presentation of the product are correct.
Company contact information
For medical information enquiries contact Tillomed Medical Information Email: pvuk@tillomed.co.uk
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Please ensure that it is passed on to paediatric wards if the product is prepared on site.
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