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en - Instructions for use
DESCRIPTION
BIOCERA-VET® OSTEOSARCOMA Ready To Use (BIO-
CERA-VET® OSA RTU) product is a synthetic, biocompatible,
osteoconductive and bioresorbable bone substitute material for
filling bone defect in weight-bearing bones. The material is ap-
plied directly into the bone defect from the syringe or with a can-
nula without any further preparation.
BIOCERA-VET® OSA RTU is a sterile single-use product,
available in two packaging sizes (12 cc and 2x 12 cc).
Thanks to its high injectability and self-setting (hardening), BIO-
CERA-VET® OSA RTU is easy and intuitive to use.
COMPOSITION
BIOCERA-VET® OSA RTU is a mineral bone cement compo-
sed of synthetic calcium and phosphate salts finely dispersed in
a biocompatible carrier liquid made from short-chain triglyceri-
des (caprylic/capric triglycerides) as well as two emulsifiers (po-
lyoxyl 35 castor oil and cetyl phosphate). Caprylic/capric trigly-
cerides and polyoxyl 35 castor oil are made from plant-based
raw materials.
The setting reaction of BIOCERA-VET® OSA RTU starts after
application upon contact with an aqueous solution, such as body
fluid. BIOCERA-VET® OSA RTU sets in situ to a microcrystal-
line, calcium-deficient hydroxyapatite (CDHA) as the main pha-
ses. The minor phase consists of calcium hydrogen phosphate
(monetite) and calcium carbonate (calcite). The chemical com-
position and crystalline structure of the final reaction product
(CDHA) correspond largely to the mineral components of natural
bone.
BIOCERA-VET® OSA RTU does not contain any substances of
animal origin, added preservatives or pharmacologically active
agents. A volume of 12 cc BIOCERA-VET® OSA RTU contains
approx. 280 mg potassium in the form of K2HPO4 (see dosage
and application).
Table 1: Composition of BIOCERA-VET® OSA RTU
Alpha-tricalcium phosphate
Calcium hydrogen phosphate (monetite)
Calcium carbonate (calcite)
Tricalcium orthophosphate (CDHA)
Dipotassium hydrogen phosphate
Miglyol 812 (caprylic/capric triglycerides)
Kolliphor ELP (polyoxyl 35 castor oil)
Amphisol A (cetyl phosphate)
INDICATIONS
BIOCERA-VET® OSA RTU is recommended as a bone substi-
tute for the cementoplasty of primary osteosarcoma tumors at
the weight-bearing bones of the appendicular skeleton.
BIOCERA-VET® OSA RTU can also be used for other indica-
tions where the bone is weakened by a disease such as other
bone tumors, metastasis, a traumatic or surgically induced in-
jury, or for filling bone defect where large volume of bone sub-
stitute is required.
2
Components
Percentage
(%)
48.35 - 49.88
20.95 - 21.61
8.06 - 8.32
3.23 - 3.33
2.41 - 2.49
11.56 - 13.68
2.11 - 2.50
0.70 - 0.82
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