Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Powder:
Sodium chloride
Human albumin
Sodium citrate
Heparin
Antithrombin III
HCl or NaOH (in small amounts for pH adjustment)

Solvent:
Water for injections
6.2   Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

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 24 hours at room temperature (max. 25 °C). However, from a microbiological point of view, the product should be used immediately.


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

Beriplex P/N 250:
Powder: Injection vial of colourless glass (Type II), sealed with latex-free infusion stopper (bromobutyl rubber), aluminium seal and plastic flip-off cap.
Solvent: 10 ml Water for injections in an injection vial of colourless glass (Type I), sealed with latex-free infusion stopper (chlorobutyl rubber), aluminium seal and plastic flip-off cap.
Injection device: 1 filter transfer device 20/20 (Mix2Vial)

Beriplex P/N 500:
Powder: Injection vial of colourless glass (Type II), sealed with latex-free infusion stopper (bromobutyl rubber), aluminium seal and plastic flip-off cap.
Solvent: 20 ml Water for injections in an injection vial of colourless glass (Type I), sealed with latex-free infusion stopper (chlorobutyl rubber), aluminium seal and plastic flip-off cap.
Injection device: 1 filter transfer device 20/20 (Mix2Vial)

Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
Method of administration

General instructions
– The solution should be clear or slightly opalescent. After filtering/withdrawal (see below) 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. Ensure product 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 package 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
2            stopper.
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 product 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 product vial stopper. The solvent will automatically flow into the product vial.
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5. With one hand grasp the product-side of the
Mix2Vial set and with the other hand grasp the solvent-side and unscrew counterclockwise the set carefully into two pieces.
Discard the solvent vial with the blue
5             Mix2Vial adapter attached.
6. Gently swirl the product 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 product vial is upright, connect the syringe to the Mix2Vial's Luer Lock fitting by screwing clockwise. Inject air into the product 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 counterclockwise.

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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.

In case more than one vial of Beriplex is required, it is possible to pool several vials of Beriplex for a single infusion via a commercially available infusion device.

The Beriplex solution must not be diluted.

The reconstituted solution should be administered by a separate injection / infusion line by slow intravenous injection, at a rate not exceeding 3 IU/kg/minute, max. 210 IU/minute, approximately 8 ml/minute.

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