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Prescribing Information 500 IU 1000 IU

Safety

Manufacturing process

Flow chart, in orange and green, stating the manufacturing stages of Voncento

Adverse reactions1

MedDRA Standard Systems Organ Class Adverse Reaction Frequency
Blood and lymphatic system disorders FVIII inhibition Uncommon (PTPs)
Very common (PUPs)
VWF inhibition Not known
Immune system disorders Hypersensitivity
(including tachycardia, chest pain, chest discomfort and back pain)
Common
Nervous system disorders Dysgeusia Uncommon
Vascular disorders Thromboembolic event Uncommon
General disorders and administration site conditions Pyrexia Common
Headache Very Common
Investigations Liver function test abnormal Uncommon

PTPs = previously-treated patients.
PUPs = previously-untreated patients.

References

1. CSL Berhing UK Limited. Voncento Summary of Product Characteristics.

Reporting adverse events

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple store Adverse events should also be reported to CSL Behring UK Ltd. on 01444 447 405.

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