INDUCTOS Powder, solvent and matrix for implantation matrix Ref.[9360] Active ingredients: Dibotermin alfa

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Medtronic BioPharma B.V., Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands, tel +31 (0) 45 566 8000, fax +31 (0) 45 566 8012

Product name and form

InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix.

Pharmaceutical Form

Powder, solvent and matrix for implantation matrix.

The powder is white. The solvent is a clear colourless liquid. The matrix is white.

Qualitative and quantitative composition

One vial contains 4 mg (4 mg pack) or 12 mg (12 mg pack) 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.

Active Ingredient 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

InductOs 4 mg pack contains:

  • Powder in a vial (10 ml; Type I glass) with a stopper (bromobutyl rubber).
  • Solvent in a vial (10 ml; Type I glass) with a stopper (bromobutyl rubber).
  • Two matrices (2.5 cm x 5 cm) in a blister package (polyvinyl chloride – PVC).
  • Two syringes (5 ml; polypropylene).
  • Two needles (stainless steel).

InductOs 12 mg pack contains:

  • Powder in a vial (20 ml; Type I glass) with a stopper (bromobutyl rubber).
  • Solvent in a vial (10 ml; Type I glass) with a stopper (bromobutyl rubber).
  • One matrix (7.5 cm x 10 cm) in a blister package (polyvinyl chloride – PVC).
  • Two syringes (10 ml; polypropylene).
  • Two needles (stainless steel).

Not all pack sizes may be marketed.

Marketing authorization holder

Medtronic BioPharma B.V., Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands, tel +31 (0) 45 566 8000, fax +31 (0) 45 566 8012

Marketing authorization dates and numbers

EU/1/02/226/001
EU/1/02/226/002

Date of first authorisation: 9 September 2002
Date of latest renewal: 20 July 2012

Drugs

Drug Countries
INDUCTOS Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom
 
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