Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Powder:
Tri-sodium citrate dihydrate, Polysorbate 80, Mannitol, Sucrose, HCl (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 injection sets should be used because treatment failure can occur as a consequence of human coagulation factor IX adsorption to the internal surfaces of some injection equipment.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.

After reconstitution the chemical and physical in-use stability has been demonstrated for 8 hours at 2-25 °C. 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 in the responsibility of the user.

6.4   Special precautions for storage

Do not store above 25 °C.
Do not freeze. Keep vials in the outer carton 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
IDELVION 250 IU powder and solvent for solution for injection
Powder (250 IU) in a 6 ml vial (type I glass), with a stopper (bromobutyl rubber) a disc (plastic) and a cap (aluminium).
2.5 ml of solvent in a vial (type I glass), with a stopper (bromo- or chlorobutyl rubber) a disc (plastic) and a cap (aluminium).

IDELVION 500 IU powder and solvent for solution for injection
Powder (500 IU) in a 6 ml vial (type I glass), with a stopper (bromobutyl rubber) a disc (plastic) and a cap (aluminium).
2.5 ml of solvent in a vial (type I glass), with a stopper (bromo- or chlorobutyl rubber) a disc (plastic) and a cap (aluminium).

IDELVION 1000 IU powder and solvent for solution for injection
Powder (1000 IU) in a 6 ml vial (type I glass), with a stopper (bromobutyl rubber) a disc (plastic) and a cap (aluminium).
2.5 ml of solvent in a vial (type I glass), with a stopper (bromo- or chlorobutyl rubber) a disc (plastic) and a cap (aluminium).

IDELVION 2000 IU powder and solvent for solution for injection
Powder (2000 IU) in a 10 ml vial (type I glass), with a stopper (bromobutyl rubber) a disc (plastic) and a cap (aluminium).
5 ml of solvent in a vial (type I glass), with a stopper (bromo- or chlorobutyl rubber) a disc (plastic) and a cap (aluminium).

Presentations

Each pack contains:
IDELVION 250 IU powder and solvent for solution for injection:
1 vial with powder
1 vial with 2.5 ml water for injections
1 filter transfer device 20/20
One inner box containing:
1 disposable 5 ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster

IDELVION 500 IU powder and solvent for solution for injection
1 vial with powder
1 vial with 2.5 ml water for injections
1 filter transfer device 20/20
One inner box containing:
1 disposable 5 ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster

IDELVION 1000 IU powder and solvent for solution for injection
1 vial with powder
1 vial with 2.5 ml water for injections
1 filter transfer device 20/20
One inner box containing:
1 disposable 5 ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster
IDELVION 2000 IU powder and solvent for solution for injection
1 vial with powder
1 vial with 5 ml water for injections
1 filter transfer device 20/20
One inner box containing:
1 disposable 10 ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster

Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
General instructions
-    The reconstituted solution should be yellow to colorless clear liquid free of visible particles. After filtering/withdrawal (see below) the reconstituted product should be inspected visually for particulate matter and discoloration prior to administration.
-    Do not use solutions that are cloudy or have deposits.
-    Reconstitution and withdrawal must be carried out under aseptic conditions.

Reconstitution
Bring the solvent to room temperature (below 25 °C). Ensure IDELVION and solvent vial flip caps are removed and the stoppers are treated with an antiseptic solution and allowed to dry prior to opening the Mix2Vial package.

1. Open the Mix2Vial by peeling off the lid. Do not remove the Mix2Vial from the blister package!
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2. Place the solvent vial on an even, clean surface and hold the vial tight. Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.

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3. Carefully remove the blister package from the
Mix2Vial set by holding at the rim, and pulling vertically upwards. Make sure that you only pull away the blister package and not the
Mix2Vial set.
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4. Place the IDELVION vial on an even and firm surface. Invert the solvent vial with the
Mix2Vial set attached and push the spike of the transparent adapter end straight down through the IDELVION vial stopper. The solvent will automatically flow into the
IDELVION vial.
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5. With one hand grasp the IDELVION side of the
Mix2Vial set and with the other hand grasp the solvent-side and unscrew the set carefully counter-clockwise into two pieces.
Discard the solvent vial with the blue Mix2Vial adapter attached.

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6. Gently swirl the IDELVION vial with the transparent adapter attached until the substance is fully dissolved. Do not shake.

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7. Draw air into an empty, sterile syringe. While the IDELVION vial is upright, connect the syringe to the Mix2Vial's Luer Lock fitting by screwing clockwise. Inject air into the
IDELVION vial.


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Withdrawal and application

8. While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly.



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9. Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe by unscrewing counter-clockwise.


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Care should be taken that no blood enters the syringe filled with product, as there is a risk that the blood could coagulate in the syringe and fibrin clots could therefore be administered to the patient.

The reconstituted IDELVION solution must not be diluted.

The reconstituted solution should be administered by slow intravenous injection. The rate of administration should be determined by the patient’s comfort level, up to a maximum of 5 ml/min.

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