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InductOs 12 mg kit for implant (2012)

Active ingredients: Dibotermin alfa

Product Name and Form

InductOs 12 mg kit for implant.

Pharmaceutical form

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.

Chemical substance
Description
Dibotermin alfa

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.

List of excipients

Powder:

Sucrose
Glycine
Glutamic acid
Sodium chloride
Polysorbate 80
Sodium hydroxide

Solvent:

Water for injections

Matrix:

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).
Marketing authorization holder
Authorization dates

Medtronic BioPharma B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands

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

Marketing authorization number:

EU/1/02/226/001