Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Powder: glycine, sodium chloride, sodium citrate, calcium chloride
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 because treatment failure can occur as a consequence of human coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.

6.3 Shelf-life
The expiry date of the product is indicate on the packaging materials After first opening, the product should be used immediately.

6.4   Special precautions for storage

Do not store above 25 °C.
Do not freeze.
Keep the vials in the outer carton in order to protect from light.


6.5   Nature and contents of container
1 package Haemoctin SDH contains:
1 vial with powder (20 ml) out of glass type I acc. to Ph.Eur.
Freeze-drying stoppers out of halobutyl-caoutchouc, type I acc. to Ph.Eur.
1 vial with solvent (5 ml, 10 ml), glass type I acc. to Ph.Eur. Injection stoppers out of halobutyl-caoutchouc, type I acc. to Ph.Eur.
The pack also contains:
1 disposable syringe (5 ml, 10 ml), 1 transfer system with integral filter, 1 butterfly cannula.

6.6   Special precautions for disposal and other handling

Reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration. The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits.

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

Instructions for use and handling:
Absolute sterility is to be ensured in all steps of the procedure!
Dissolution of the concentrate:
• Bring the unopened vials of the solvent (water for injections) and product to room temperature.
If a water bath is used for warming, it must be scrupulously ensured that the water does not come into contact with the caps or stoppers of the vials. Otherwise contamination of the medicine may occur.
• Remove the caps from both vials in order to expose the central portions of the rubber stoppers (1). Ensure that the rubber stoppers of the product and solvent vials are treated with a disinfectant.
• Remove the top of the transfer system packaging (2) Place the blue part of the transfer system onto the upright standing vial containing the solvent (3).
• Remove the remaining part of the packaging of the transfer system. Now the transparent part of the transfer system is visible.
• Place the product vial on an even surface.
• Turn the combination of transfer system and solvent vial upside down. Push the spike of the transparent part of the adapter straight down through the product vial stopper (4).
The vacuum present in the product vial causes the solvent to flow into the product vial. (5)
Immediately unscrew the blue part of the transfer system together with the solvent vial.
Discard the solvent vial with the blue part of the transfer system attached (6). Gently swirling the product vial helps in dissolving the powder. Do not shake vigorously, all foaming is to be avoided! The solution is clear or slightly opalescent.

The solution ready for use should be used immediately after dissolving. Do not use solutions that are cloudy or contain visible particles.
Injection:
•      Once you have dissolved the powder as described above, screw the enclosed syringe with its Luer-Lock connector onto the product vial with the transparent part of the transfer system. (7) This allows you to easily draw the dissolved drug into the syringe. A separate filter is not necessary because the transfer system has its own integral filter.
• Carefully disconnect the vial with the transparent part of the transfer system from the syringe. Use the enclosed butterfly needle and administer immediately by slow intravenous injection. The injection rate must not exceed: 2 - 3 ml/minute.
•      After the butterfly needle has been used, it can be made safe with the protective cap.