Pharmaceutical particulars : מידע רוקחי

6         PHARMACEUTICAL PARTICULARS
6.1       List of excipients

Succinic acid.

6.2       Incompatibilities
Although no chemical/pharmaceutical incompatibilities have been found, Fomicyt solutions should not be mixed together with other parenteral preparations with the exception of those listed in section 6.6.

6.3        Shelf life

The expiry date of the product is indicated on the packaging materials.
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 the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, protected from light, unless preparation has taken place in controlled and validated aseptic conditions.


6.4        Special precautions for storage

Store below 30 °C.

For storage of the solution for infusion see section 6.3.
6.5        Nature and contents of container
Clear type-I glass bottles with a rubber stopper (bromobutyl rubber) and pull-off cap Containing
• 2 g (in 30 ml bottle) in packs of 10 bottles each
• 4 g (in 30 ml bottle) in packs of 10 bottles each
• or 8 g (in 50 ml bottle) in packs of 10 bottles each.

Not all pack sizes may be marketed.

6.6        Special precautions for disposal and other handling
For single use only.

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

Preparation of the solution for infusion

FOMICYT must be reconstituted and diluted prior to administration.
Water for Injections and Glucose Infusion 50 mg/ml (5 %) or Glucose Infusion 100 mg/ml (10 %) may be used as solvent for the reconstitution and dilution. Sodium chloride containing solvents must not be used (see section 4.4).

Reconstitution

Shake the vial prior to the reconstitution to loosen up the powder. Reconstitute the 2 g or 4 g vials with 20 ml and the 8 g vial with 40 ml of solvent. Shake well to dissolve. A slight degree of warming occurs when the powder is dissolved.

Caution: This intermediate solution is not for direct infusion. Withdraw the solution completely from the original vial. Transfer the withdrawn solution into an infusion bag or other suitable infusion container for further dilution as follows.

Dilution

Transfer the reconstituted contents of 2 g vials into an infusion container with further 30 ml of solvent.
Transfer the reconstituted contents of 4 g vials into an infusion container with further 80 ml of solvent.
Transfer the reconstituted contents of 8 g vials into an infusion container with further 160 ml of solvent.

The resulting solution for infusion is clear and colourless to slightly yellowish.

Displacement value
The displacement values for the solutions are 1 ml for the 2 g pack size, 2 ml for the 4 g pack size and 4 ml for the 8 g pack size.

These volumes are equivalent to an increase of volume of 2 %. This has to be considered when not the entire volume of the final diluted solution is used.