Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Histidine,
Mannitol,
Sodium chloride,
HCl or NaOH (in small amounts for pH adjustment)
Supplied solvent:
Water for injections

6.2   Incompatibilities

This medicinal product must not be mixed with other medicinal products, solvents and diluents, except those mentioned in section 6.1 and normal saline.

6.3   Shelf life

2 years.
The made up solution should be used immediately.
However, After reconstitution or After dilution (up to 1:10) of the reconstituted Mononine 1000 solution, the physico-chemical stability has been demonstrated for 24 hours at up to max +25ºC.

6.4   Special precautions for storage

Store in a refrigerator (2 °C - 8 ºC). Do not freeze. Keep the vial in the outer carton in order to protect from light.

During its shelf-life, the product (when kept in its outer carton) may be stored at ambient room temperature (up to 25 °C) for up to 1 month without being refrigerated again during this period. The date of transfer to room temperature and the end of the 1-month period should be recorded on the outer carton. At the end of this period the product has to be used or discarded.

6.5   Nature and contents of container

Immediate containers
1000 IU powder and 10 ml solvent in vials (Type I glass) with stoppers (chlorobutyl rubber).

Presentation
One pack with 1000 IU containing:
- 1 vial with powder
- 1 vial with 10 ml water for injections
One device pack containing:
- 1 filter transfer device 20/20
- 1 disposable 10 ml syringe
- 1 venipuncture set
- 2 alcohol swabs
- 1 non-sterile plaster

6.6   Special precautions for disposal and other handling
General instructions
– Reconstitution and withdrawal must be carried out under aseptic conditions.
– Usually the solution is clear or slightly opalescent. Reconstituted product should be inspected visually for particulate matter and discoloration after filtering/withdrawal (see below) and prior to administration. Do not use solutions which are cloudy or contain residues (deposits/ particles).

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 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 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,
invert 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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Administer immediately by slow intravenous injection or infusion (see section 4.2) 
Any unused product or waste material should be disposed of in accordance with local requirements.