TheraVet BIOCERA-VET BONE SURGERY Ready To Use Instructions D'utilisation page 6

DISPOSAL
No special disposal measures are required for unopened pro-
ducts. Explanted or contaminated material must be disposed of
in accordance with the veterinary practices' standard disposal
procedure.
CONTRAINDICATIONS
BIOCERA-VET® BS RTU must not be used in case of:
 acute or chronic infections at the implantation site, e.g. os-
teomyelitis
 bone defects adjacent to open epiphyseal plates
 cranioplasty
 pregnant or nursing animals
 known intolerance to an ingredient of BIOCERA-VET® BS
RTU (see composition)
BIOCERA-VET® BS RTU must be used only after carefully
weighing the risks and benefits in the case of:
 disorders of the bone metabolism
 endocrinopathies
 immunosuppressive therapy
 simultaneous therapy with medicines that influence bone
metabolism
USE DURING PREGNANCY OR LACTATION
No clinical data for use in pregnant or lactating animal is
available. Therefore, BIOCERA-VET® BS RTU should not be
used during pregnancy or lactation.
USE IN PUPPIES
There are no clinical known reasons that would restrict use in
puppies and young animals.
INTERACTIONS
If the patient is being treated simultaneously with resorption-in-
hibiting substances (particularly bisphosphonates, long term tre-
atments with NSAIDs – non-steroidal anti-inflammatory drugs),
slower resorption of the implant material should be assumed.
No additional interactions with other medical devices or medi-
cinal products are known, as long as they do not have a direct
effect on bone metabolism. BIOCERA-VET® BS RTU is a non-
metallic, non-conducting and non-magnetic bone substitute ma-
terial and therefore is designated as MRI safe.
PRECAUTIONS AND WARNINGS
The use of BIOCERA-VET® BS RTU is restricted to specialists
who are familiar with handling bone substitute materials, the ap-
propriate surgical techniques, and the treatment of bone defects
from their training.
When using BIOCERA-VET® BS RTU, as with all surgical inter-
ventions, surgery-related risks may occur, particularly rejection
reactions, pseudarthrosis, swelling, seroma and hematoma for-
mation, pain, and wound healing disorders. Subsequent revision
operations may become necessary.
Patients with weaker immune systems are at a higher risk of in-
fections and implant failure. Owners of such patients must be
informed by medical staff of the possible risks before surgery.
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