Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
Sodium acetate trihydrate
Glacial acetic acid
Water for injection

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.
From a microbiological point of view, the product must be used immediately after dilution. If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user and shall not exceed 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.


6.4 Special precautions for storage
Store below 25ºC. For storage conditions of the diluted medicinal product, see section 6.6.
6.5 Nature and contents of container
Glass type I vial with a 7 ml capacity. Each vial contains 5 ml concentrate for solution for infusion and is closed by a chlorobutyl rubber stopper with an aluminium flip cap.
Each carton contains 10 vials.

6.6 Special precautions for disposal and other handling
See Table 1 for the recommended preparation and administration of Levetiracetam Altan 100 mg/ml concentrate for solution for infusion to achieve a total daily dose of 500 mg, 1,000 mg, 2,000 mg, or 3,000 mg in two divided doses.

Table 1. Preparation and administration of Levetiracetam Altan 100 mg/ml concentrate for solution for infusion Dose        Withdrawal Volume              Volume of      Infusion      Frequency of         Total Daily Diluent        Time          Administration Dose
250 mg      2.5 ml (half 5 ml vial)        100 ml         15 minutes    Twice daily          500 mg/day
500 mg      5 ml (one 5 ml vial)           100 ml         15 minutes    Twice daily          1000 mg/day 1000 mg 10 ml (two 5 ml vials)             100 ml         15 minutes    Twice daily          2000 mg/day 1500 mg 15 ml (three 5 ml vials)           100 ml         15 minutes    Twice daily          3000 mg/day 
This medicinal product is for single use only, any unused solution should be discarded.

Levetiracetam Altan 100 mg/ml concentrate for solution for infusion was found to be physically compatible and chemically stable for at least 24 hours when mixed with the following diluents and stored in PVC bags at controlled room temperature 15-25°C.

Diluents:
• Sodium chloride 9 mg/ml (0.9%) solution for injection
• Lactated Ringer's solution for injection
• Dextrose 50 mg/ml (5%) solution for injection
Medicinal product with particulate matter or discoloration should not be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.