InductOs 12 mg kit for implant (2012)
Active ingredients: Dibotermin alfa
Product Name and Form
InductOs 12 mg kit for implant.
Kit for implant.
The kit consists of a white powder for solution, a clear colourless solvent and a white matrix.
Qualitative and Quantitative Composition
One vial contains 12 mg dibotermin alfa. After reconstitution, InductOs contains 1.5 mg/ml dibotermin alfa.
Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2; rhBMP-2) is a human protein derived from a recombinant Chinese Hamster Ovary (CHO) cell line.
For the full list of excipients, see section 6.1.
Dibotermin alfa is an osteoinductive protein that results in the induction of new bone tissue at the site of implantation. Dibotermin alfa binds to receptors on the surface of mesenchymal cells and causes cells to differentiate into cartilage- and bone-forming cells. The differentiated cells form trabecular bone as the matrix is degraded, with vascular invasion evident at the same time.
Water for injections
Bovine Type I collagen
Pack sizes and Marketing
Each kit of InductOs is provided with:
- 12 mg of sterile dibotermin alfa powder in a 20 ml vial (Type I glass) stoppered with a bromobutyl rubber closure sealed with an aluminum flip-off seal and plastic cap.
- Solvent for reconstitution in a 10 ml vial (Type I glass) stoppered with a bromobutyl rubber closure sealed with an aluminum flip-off seal and plastic cap.
- One sterile matrix in a polyvinyl chloride (PVC) blister package sealed with a Tyvek lid.
- Two sterile 10 ml disposable polypropylene syringes.
- Two sterile needles (stainless steel).
Medtronic BioPharma B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
tel +31 (0) 45 566 8000
fax +31 (0) 45 566 8012
Date of first authorisation: 9 September 2002
Date of latest renewal: 24 July 2012