The Summary of Product Characteristics (SPC) for Phenoxypen Water Soluble Powder, 325 mg/g Powder for Use in Drinking Water for Pigs and Chickens has been updated
Pigs have been added as a target species (Section 4.1) with the indication (Section 4.2) stating Treatment and metaphylaxis of infections caused by Streptococcus suis. The presence of the disease in the group must be established before the product is used.
Further information for use in pigs has been added to sections 4.9 (Amounts to be administered and administration route), 4.10 (Overdose), 4.11 (Withdrawal periods), and 5.2 (Pharmacokinetic particulars).
Section 4.4 (Special warnings for each target species) has also been updated stating Cross-resistance has been shown between phenoxymethylpenicillin and other beta-lactam antibiotics. Use of the product should be carefully considered when susceptibility testing has shown resistance to beta-lactam antibiotics because its effectiveness may be reduced.
Any veterinary medicinal product which is authorised for marketing in the United Kingdom will have its Summary of Product Characteristics (SPC) available on our Product Information Database.
No medicine is 100% risk free, the SPC includes information on what adverse events have been known to occur following administration of a particular product, these can be found in either section Adverse events (3.6) or Adverse reactions (4.6).
Reporting of adverse events
We strongly encourage anyone who is aware of an adverse event to report to the Marketing Authorisation Holder (pharmaceutical company, MAH) or the VMD. Provide all relevant information, including the batch number.
Contact details for the MAH can be found on the product leaflet, on the Product Information Database Product Information Database – Home or on the MAH’s website.
You can report directly to the VMD at Report a suspected problem with an animal medicine – GOV.UK.
You only need to report once, either to the VMD or the MAH. Reporting to both may create duplicate reports which affects the efficiency of our data handling or the quality of the data we hold.
The reporting of adverse events is critical to our ongoing monitoring activities in order to protect animal health, public health, and the environment. Find out more about pharmacovigilance at Monitoring the safety of animal medicines – GOV.UK.
Sign up to receive safety updates at Urgent and clinically significant safety updates for veterinary medicines – GOV.UK.
