Source: United Kingdom – Executive Government & Departments
StromEase 25 mg/ml Eye Drops, Solution for Dogs and Cats – SPC change
Change to the information provided on adverse events in the Summary of Product Characteristics for StromEase 25 mg/ml Eye Drops, Solution for Dogs and Cats.
Following monitoring of pharmacovigilance data, the Summary of Product Characteristics (SPC) for StromEase 25 mg/ml Eye Drops, Solution for Dogs and Cats has been updated.
Section 4.6 has been amended to clarify that irritation or inflammation of the eye and/or its adnexa have been reported in very rare cases, especially blinking of the eyelids or even closure of the eye, eye redness or conjunctival oedema, particularly in dogs.
The frequency of adverse reactions is defined using the following convention:
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very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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common (more than 1 but less than 10 animals in 100 animals treated)
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uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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rare (more than 1 but less than 10 animals in 10,000 animals treated)
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very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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).
All updates to SPCs other than template changes, are published in the medicine updates section of VMD Connect.