Problem Or Issue:
The European Medicines Agency has completed a review of Tazocin (piperacillin/tazobactam). The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Tazocin in the European Union (EU).
The areas of the Summary of Product Characteristics (SmPC) harmonised include the following:
- Therapeutic Indications (SmPC section 4.1), the indications remain essentially unchanged in Ireland. A summary of the indications is provided below under the section Further Information.
- Posology and method of administration (SmPC section 4.2), this section now only refers to administration by intravenous infusion (over 30 minutes). Reference to administration by slow intravenous injection (over at least 3-5 minutes) has been removed.
- Consequential to the change in the method of administration, sections 1 and 3 of the SmPC have also been changed to remove reference to injection. The pharmaceutical form previously stated ‘powder for solution for injection or infusion’ this has therefore been replaced with ‘powder for solution for infusion’.
- The dosage regimen for certain patients groups e.g. those with renal impairment has been revised during the harmonisation process. More information on the updated SmPC section 4.2 is provided below under the section Further Information.
- The Committee also harmonised other sections of the SmPC including the sections on contraindications (SmPC section 4.3), special warnings and precautions for use (SmPC section 4.4), fertility, pregnancy and lactation (SmPC section 4.6). Please refer to updated SmPC’s for further details on these sections.
As a result of the EU harmonisation referral procedure, the product information (SmPC, package leaflet and labelling) for Tazocin and consequentially all generic piperacillin/tazobactam products has been updated.