Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Powder
Glycine
Sucrose
Histidine
Sodium chloride
Calcium chloride dihydrate
Polysorbate 80
Acetic acid, glacial (for pH adjustment)

Solvent
Water for injections

6.2   Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Only the provided infusion sets should be used for reconstitution and injection because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.

6.3   Shelf-life

The expiry date of the product is indicated on the packaging materials.
The chemical and physical in-use stability after reconstitution has been demonstrated for 3 hours at room temperature.
After reconstitution, from a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Do not refrigerate after reconstitution.

6.4   Special precautions for storage
Store in a refrigerator (2 °C - 8 °C).
Do not freeze.
Keep the vial and the pre-filled syringe in the outer carton in order to protect from light.

Within its overall shelf life of 30 months the product when kept in its outer carton, may be stored up to 25 °C for a limited period of 12 months. In this case, the product expires at the end of this 12-month period or the expiry date on the product vial, whichever is earlier. The new expiry date must be noted on the outer carton.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5   Nature and contents of container and special equipment for use, administration or implantation

Each package of Kovaltry contains:
•     one vial with powder (10 mL clear glass type 1 vial with grey halogenobutyl rubber blend stopper and aluminium seal)
•     one pre-filled syringe with 2.5 mL (for 250 IU, 500 IU and 1000 IU) or 5 mL (for 2000 IU) solvent (clear glass cylinder type 1 with grey bromobutyl rubber blend stopper)
•     syringe plunger rod
•     vial adapter
•     one venipuncture set 
6.6   Special precautions for disposal and other handling

Detailed instructions for preparation and administration are contained in the package leaflet provided with Kovaltry.

The reconstituted medicinal product is a clear and colourless solution.
Kovaltry powder should only be reconstituted with the supplied solvent (2.5 mL or 5 mL water for injections) in the prefilled syringe and the vial adapter. For infusion, the product must be prepared under aseptic conditions. If any component of the package is opened or damaged, do not use this component.
After reconstitution the solution is clear. Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration. Do not use Kovaltry if you notice visible particulate matter or turbidity.

After reconstitution, the solution is drawn back into the syringe. Kovaltry should be reconstituted and administered with the components (vial adapter, prefilled syringe, venipuncture set) provided with each package.

The reconstituted product must be filtered prior to administration to remove potential particulate matter in the solution. Filtering is achieved by using the vial adapter.
The venipuncture set provided with the product must not be used for drawing blood because it contains an in-line filter.

For single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.