Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Powder:         Sodium chloride
Trisodium citrate dehydrate

Solvent:        Water for Injection

6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except the solvent mentioned in section 6.6.
As in all blood coagulation preparations, the efficacy and tolerance of the medicinal product may be impaired by being mixed with other medicinal products. It is advisable to rinse a common venous access with a suitable solution, e.g., with isotonic saline solution, before and after the administration of FEIBA.
Coagulation factors derived from human plasma may be adsorbed by the inner surfaces of certain types of injection/infusion devices. If this were to occur, it could result in failure of therapy. Therefore, only approved plastic infusion devices may be used with FEIBA.

6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.

Chemical and physical in-use stability has been demonstrated for 3 hours at room temperature (up to 25°C).
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination (controlled and validated aseptic conditions), the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Reconstituted product must not be refrigerated.

6.4 Special precautions for storage
Do not store above 25° C. Do not freeze.

Store in the original package in order to protect from light.

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

6.5 Nature and contents of container

The powder is supplied in a vial made of surface-treated, colourless glass (hydrolytic type II). The solvent is supplied in a vial made of surface treated, colourless glass (hydrolytic class I). The vials are closed by a stopper, made of butyl rubber.

Each package contains either:
- 1 vial with FEIBA 1000 U (powder for solution for infusion or injection) - 1 vial with 20 ml Water for Injections
- 1 disposable syringe (20 ml capacity)
- 1 disposable needle
- 1 butterfly needle
- 1 filter needle
- 1 transfer needle
- 1 aeration needle or
- 1 vial with FEIBA 1000 U (powder for solution for infusion or injection) - 1 vial with 20 ml Water for Injections
- 1 BAXJECT II Hi-Flow
- 1 disposable syringe
- 1 disposable needle
- 1 butterfly needle6.6. Special precautions for disposal and other handling 
FEIBA is to be reconstituted immediately prior to administration. The solution should be used immediately (as the preparation does not contain preservatives).
Swirl gently until all material is dissolved. Ensure that FEIBA is completely dissolved; otherwise, less FEIBA Units will pass through the device filter.
After reconstitution, the solution should be inspected for particulate matter and discoloration prior to administration. Do not use solutions which are cloudy or have deposits.

Open containers must not be re-used.
Do not use the product if its sterile barrier has been breached, its package damaged or if it shows signs of deterioration.
Use only the included Water for Injections and the included device set for reconstitution. If devices other than those enclosed are used, ensure the use of an adequate filter with a pore size of at least 149 µm.

Do not refrigerate after reconstitution.

After complete reconstitution of FEIBA, its injection or infusion should be commenced immediately and must be completed within three hours following reconstitution.
Any unused medicinal product or waste material        should be disposed of in accordance with local requirements.

Reconstitution of the powder for preparing a solution for injection or infusion with needles:
1. Warm the unopened solvent vial (Water for Injections) to room temperature or max. +37°C if necessary.
2. Remove the protective caps from the powder vial and solvent vial (Fig. A) and disinfect the rubber stoppers of both vials.
3. Open the protective cap from one end of the enclosed transfer needle by twisting, remove it and insert the needle through the rubber stopper of the solvent vial (Fig. B and C).
4. Remove the protective cap from the other end of the transfer needle taking care not to touch the exposed end!
5. Invert the solvent vial and insert the free end of the transfer needle through the rubber stopper of the powder vial (Fig. D). The solvent will be drawn into the powder vial by vacuum.
6. Disconnect the two vials by removing the transfer needle from the powder vial (Fig. E).
Gently swirl the powder vial to accelerate dissolution.
7. Upon complete reconstitution of the powder, insert the enclosed aeration needle (Fig. F) and any foam will collapse. Remove the aeration needle.


Infusion/ Injection:
1. Open one end of the protective cap from the enclosed filter needle by twisting, remove it and fit the needle on to the sterile disposable syringe. Draw the solution into the syringe (Fig. G).
2. Disconnect the filter needle from the syringe and slowly administer the solution intravenously with the enclosed infusion set (or the enclosed disposable needle).



Fig. A      Fig. B        Fig. C      Fig. D      Fig. E      Fig. F Fig. G 
Reconstitution of the powder for preparing a solution for infusion with the BAXJECT II Hi-Flow:

1.    Warm the unopened solvent vial (Water for Injections) to room temperature (15 °C to 25 °C), for example by using a water bath for several minutes (max. 37 °C) if necessary.
2.    Remove the protective caps from the powder vial and solvent vial and disinfect the rubber stoppers of both vials. Place the vials on an even surface.
3.    Open the packaging of the BAXJECT II Hi-Flow by pulling off the protective foil without touching the contents of the package (Fig. a). Do not remove the transfer system from the package at this point.
4.    Turn the package around and press the transparent plastic pin through the rubber stopper of the solvent vial (Fig. b). Now remove the packaging from the BAXJECT II Hi-Flow (Fig. c). Do not remove the blue protective cap from the BAXJECT II Hi-Flow.

5. Now turn the system, consisting of the BAXJECT II Hi-Flow and the solvent vial, in such a way that the solvent vial is on top. Press the purple pin of the BAXJECT II Hi-Flow through the FEIBA vial. The solvent is drawn into the FEIBA vial by vacuum (Fig. D.).
6.   Swirl, but do not shake the entire system gently until the powder is dissolved. Make sure that the FEIBA has been dissolved completely, as active material may otherwise be retained by the filter in the system.



Infusion

1.     Remove the blue protective cap from the BAXJECT II Hi-Flow. Tightly connect the syringe to the BAXJECT II Hi-Flow. DO NOT DRAW AIR INTO THE SYRINGE (Fig. e). In order to ensure tight connection between syringe and BAXJECT II Hi-Flow, the use of a luer lock syringe is highly recommended (turn syringe in clockwise direction until stop position when mounting).
2.     Invert the system so that the dissolved product is on top. Draw the dissolved product into the syringe by pulling the plunger back SLOWLY and ensure that the tight connection between BAXJECT II Hi-Flow and the syringe is maintained throughout the whole pulling process (Fig. f).
3.     Disconnect the syringe.
4.     If foaming of the product in the syringe occurs, wait until the foam is collapsed. Slowly administer the solution intravenously with the enclosed infusion set (or disposable needle).



Do not exceed an infusion rate of 2 U FEIBA/kg body weight per minute.

7. REGISTRATION NUMBER
FEIBA 1000 U: 026 15 25390 00