SPC Update - Librela Solution for Injection for Dogs

Change to the information provided on adverse events in the Summary of Product Characteristics (SPC)

SPC Update - Librela Solution for Injection for Dogs

Following monitoring of pharmacovigilance data, the Summary of Product Characteristics (SPC) in Great Britain for the following have been updated.

• Librela 5mg Solution for Injection for Dogs

• Librela 10mg Solution for Injection for Dogs

• Librela 15mg Solution for Injection for Dogs

• Librela 20mg Solution for Injection for Dogs

• Librela 30mg Solution for Injection for Dogs

Section 4.6 now additionally states that in very rare cases, joint swelling, joint pain, bone and joint disorder and soft tissue ossification have been reported. Further details are provided in the associated footnote:

New bone formation, coupled with joint swelling and/or pain, affecting the periosteum, joint capsule and adjacent soft tissues has been observed following repeated administration.

Radiographically or on cross sectional imaging this is defined by extensive, irregular periosteal and ectopic mineralized tissue formation that extends beyond normal chondro-osseous margins into the metaphyseal and, in some cases, diaphyseal regions of adjacent bones. Bone alterations, including focal osteolysis or erosions may be observed. These changes may present unilaterally or bilaterally, can affect multiple joints, may be progressive and in very rare cases have been associated with fracture.

A special precaution for use has also been added to Section 4.5 (Special precautions for use in animals) stating that where a dog presents with new or increased joint swelling and/or joint pain following Librela treatment (see section 4.6), consideration should be given to perform additional diagnostics and discontinue treatment on a case-by-case basis.

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.