TheraVet BIOCERA-VET OSTEOSARCOMA Ready to use Instructions D'utilisation page 6

ADDITIONAL NOTIFICATIONS
Caution: Federal (USA) law restricts this device to be used by or
on the order of a licensed veterinarian.
For animal use only.
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® OSA 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®
OSA RTU (see composition)
BIOCERA-VET® OSA 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® OSA 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 animal.
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 medicinal
products are known, as long as they do not have a direct effect
on bone metabolism.
BIOCERA-VET® OSA RTU is a non-metallic, non-conducting
and non-magnetic bone substitute material and therefore is de-
signated as MRI safe.
PRECAUTIONS AND WARNINGS
The use of BIOCERA-VET® OSA RTU is restricted to specia-
lists who are familiar with handling bone substitute materials, the
appropriate surgical techniques, and the treatment of bone de-
fects from their training.
When using BIOCERA-VET® OSA RTU, as with all surgical in-
terventions, surgery-related risks may occur, particularly rejec-
tion reactions, pseudarthrosis, swelling, seroma and
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