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hematoma formation, pain, and wound healing disorders. Sub-
sequent revision operations may become necessary.
Patients with weaker immune systems are at a higher risk of in-
fections and implant failure. Owner of such patients must be in-
formed by medical staff of the possible risks before surgery.
The treatment of post-operative infections may be hampered by
the presence of an implanted foreign body and it may prove ne-
cessary to remove the implanted material.
Conventional surgical tools that are part of the standard
equipment in the operating theatre can be used to remove bone
substitute.
Any implanted foreign body can lead to fever or an allergic or
inflammation reactions.
In humans, very rare cases of allergic reactions and anaphylac-
tic shock have been reported in literature associated with the
component macrogolglycerol ricinoleate Ph. Eur. polyoxyl 35
castor oil, which is contained in BIOCERA-VET® OSA RTU. In
dogs, no toxic and allergic reactions have been reported after
local injection of polyoxyl 35 castor oil.
For patients with severely impaired kidney or liver function or
adrenal insufficiency, the additional intake of small amounts of
potassium can increase the danger of hyperkalemia or aggra-
vate the existing condition. This is also the case for patients with
reduced renal potassium excretion induced by the use of medi-
cines (e.g. heparin, ACE inhibitors, potassium-sparing diuretics,
spironolactone, non-steroidal anti-inflammatory drugs, cyclos-
porin A). Since potassium is only successively released from BI-
OCERA-VET® OSA RTU and the amount of potassium contai-
ned in BIOCERA-VET® OSA RTU corresponds to only a frac-
tion of the amount present in the daily nutritional intake, a low
risk can be assumed, even with severely impaired kidney func-
tion.
BIOCERA-VET® OSA RTU must only be implanted after suffi-
cient debridement of the bone defect in order to ensure a vital
bone site. The defect must be completely filled in order to estab-
lish direct osseous contact between BIOCERA-VET® OSA RTU
and the surrounding bone.
When injecting BIOCERA-VET® OSA RTU into a bone defect,
it must be ensured that the material does not escape into ad-
jacent soft tissue or blood vessels. To prevent an embolism, it
must be ensured that no material is inserted into open veins or
arteries, particularly when inserting BIOCERA-VET® OSA RTU
under pressure into defects that are enclosed on all sides.
When BIOCERA-VET® OSA RTU is injected into heavily blee-
ding bone defect, the material may be pushed out again through
bleeding pressure. It is recommended to monitor bleeding be-
fore applying BIOCERA-VET® OSA RTU and to continue filling
the defect only when bleeding is under control.
Due to its mechanical properties, BIOCERA-VET® OSA RTU
can support the stabilization of bone, but the actual stabilization
must be ensured by other means.
BIOCERA-VET® OSA RTU must not be mixed with aqueous
solutions, including those of autologous or allogenic origin (e.g.
blood) as this results in changes to the material properties.
BIOCERA-VET® OSA RTU is resorbed by biological processes
and replaced by the body's own bone. BIOCERA-VET® OSA
RTU resorbs slowly. Depending on the implantation conditions
and the metabolic activity at the implantation site,
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