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TheraVet BIOCERA-VET GRANULES Instructions D'utilisation page 5

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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 nec-
essary to remove the implanted material.
Any implanted foreign body can lead to fever or an allergic re-
actions or inflammation.
Very rare cases of allergic reactions and anaphylactic shock to
the component Macrogolglycerol ricinoleate Ph. Eur., which is
used in the manufacturing of BIOCERA-VET® GRANULES, are
described in the literature. Despite the steps to remove this dur-
ing the manufacturing process, traces of this substance may still
be present in the product.
In order to avoid delays during the surgical procedure, it should
be ensured prior to treatment that a sufficient number of BIOC-
ERA-VET® GRANULES units is available, e.g. in the form of
multipacks, to fill the bone defect completely. Any unused con-
tent of opened or damaged packages must not be used for fur-
ther operations and must be discarded.
For patients with severely impaired kidney function, adrenal in-
sufficiency or liver cirrhosis, the additional intake of small
amounts of potassium can increase the danger of hyperkalemia
or aggravate the existing condition. This is also the case for pa-
tients with reduced renal potassium excretion induced by the
use of medicinal products (e.g. heparin, ACE inhibitors, potas-
sium-sparing diuretics, spironolactone, non-steroidal anti-in-
flammatory drugs, cyclosporin A). In particular when large
amounts of implanted BIOCERA-VET® GRANULES are used,
serum potassium levels must be monitored.
Patients with weaker immune systems are at higher risks of in-
fections and implant loss. Owner of such patients should be in-
formed by medical staff of the possible risks before surgery.
SIDE EFFECTS
No serious side effects attributable to BIOCERA-VET® GRAN-
ULES are known.
MANUFACTURING
Manufactured by:
INNOTERE GmbH
Meissner Str. 191
01445 Radebeul
GERMANY
+49 351 2599 9410
www.innotere.de
For TheraVet SA:
TheraVet
32/1, Avenue Jean Mermoz
6041 GOSSELIES
BELGIUM
www.thera.vet
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