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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
cement.
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® BS 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® BS RTU and the amount of potassium contained
in BIOCERA-VET® BS RTU corresponds to only a fraction of
the amount present in the daily nutritional intake, a low risk can
be assumed, even with severely impaired kidney function.
BIOCERA-VET® BS RTU must only be implanted after sufficient
debridement of the bone defect to ensure a vital bone site. The
defect must be completely filled in order to establish direct osse-
ous contact between BIOCERA-VET® BS RTU and the
surrounding bone.
When applying BIOCERA-VET® BS RTU into a bone defect, it
must be ensured that the material does not escape into adjacent
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® BS RTU under
pressure into defects that are enclosed on all sides.
When BIOCERA-VET® BS RTU is applied into heavily bleeding
bone defects, the material may be pushed out again through
bleeding pressure. It is recommended to monitor bleeding be-
fore applying BIOCERA-VET® BS RTU and to continue filling
the defect only when bleeding is under control.
Due to its mechanical properties, BIOCERA-VET® BS RTU can
support the stabilization of bone defects, but the actual stabiliza-
tion must be ensured by other means.
BIOCERA-VET® BS RTU must not be mixed with aqueous so-
lutions, including those of autologous or allogenic origin (e.g.
blood) as this results in changes to the material properties.
BIOCERA-VET® BS RTU is resorbed by biological processes
and replaced by the body's own bone. BIOCERA-VET® BS RTU
resorbs slowly. Depending on the implantation conditions and
the metabolic activity at the implantation site, BIOCERA-VET®
BS RTU can also remain permanently in the body as an osseous
integrated material.
Any unused content of opened or damaged packages must not
be used for further operations and must be discarded (see dis-
posal).
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