OSIGRAFT Powder for suspension for implantation Ref.[9362] Active ingredients: Eptotermin alfa

Posology

Osigraft should be used by an appropriately qualified surgeon.

The recommended dose is one single administration in adults. Depending on the size of the bone defect, more than one 1 g vial of Osigraft may be required. The recommended maximum dose should not exceed 2 vials since efficacy in the treatment on non-unions requiring higher doses has not been established.

Paediatric population

Osigraft is contraindicated in children and adolescents (less than 18 years old) and the skeletally immature (see section 4.3).

Method of administration

Intraosseous use.

The reconstituted product is administered by direct surgical placement at the non-union site in contact with the prepared bone surface. The surrounding soft tissues are then closed around the implant. Experience from controlled clinical trials is limited to stabilisation of the fracture by intramedullary nailing.

1. Using sterile technique, remove the vial from its packaging.
2. Lift the plastic flip-top and remove the crimp from the vial. Handle the crimp with care. The edges of the crimp are sharp and may cut or damage gloves.
3. Using your thumb, pry up the edge of the stopper. Once the vacuum is broken, remove the vial stopper while holding the vial upright to prevent loss of powder. Do not insert a needle through the stopper. Puncture of the stopper with a needle may result in particles of stopper material contaminating the powder.
4. For instructions on reconstitution of the medicinal product before administration, see section 6.6.
5. Debride fibrous, necrotic or sclerotic tissue and appropriately decorticate bone fragments so that the reconstituted Osigraft is in direct contact with bleeding bone and viable osseous tissue.
6. Provide adequate haemostasis to ensure that the implanted material is not dislodged from the surgical site. Irrigate as necessary prior to the implantation of Osigraft. Where practical, surgical manipulations to the site should be completed prior to implantation of the product.
7. Apply the reconstituted product to the prepared osseous site using a sterile instrument such as a spatula or curette. The amount of Osigraft used should approximate the size of the bone defect.
8. Do not use suction or irrigation directly at the implant site as the particles of Osigraft may be removed. Remove excess fluid if necessary by suctioning adjacent to the implant site or carefully blotting the area with sterile sponge.
9. Close soft tissues around the defect containing the product using suture material of choice. Closure is critical for containment of the implant in the area of the bone defect.
10. After closure of the soft tissues around the bone defect, irrigate field if necessary to remove any of the product which may have become dislodged during soft tissue closure.
11. Do not place a drain directly in the implant site. If required, place it subcutaneously.

No case of overdose has been reported.

Shelf life: 3 years.

The reconstituted product should be used immediately.

Store in a refrigerator (2°C-8°C).

Powder in a glass vial (Type 1, borosilicate) sealed with a stopper (butyl rubber) and a crimp cap (aluminium).

The primary package is maintained sterile within a blister pack, comprised of two (inner and outer) plastic trays and lids.

Pack size of 1 vial.

Reconstitution

Each vial of Osigraft is reconstituted with 2 to 3 ml of sterile 9 mg/ml sodium chloride solution (0.9% w/v) prior to use. Sterile sodium chloride solution for injection and contents of the Osigraft vial are transferred to a sterile bowl and mixed with a sterile spatula or curette. To avoid breakage, do not tap the bottom of the vial when transferring contents. After reconstitution, the single use suspension for implantation should be used immediately.

Administration

When reconstituted, Osigraft has the consistency of wet sand, which facilitates its implantation and placement at bone site defects.

Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.