Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
Glacial acetic acid
Sodium hydroxide
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 should 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 would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions. The product is physically compatible and chemically stable for 48 hours when mixed with the below mentioned diluents and stored at room temperature.
6.4 Special precautions for storage
Store below 25ºC. For storage conditions of the diluted medicinal product, see section 6.3.

6.5 Nature and contents of container
5 ml glass vials (type I) closed by a Teflon faced stopper with an aluminium/polypropylene flip-off seal cap.

Vials containing 5 ml concentrate.
Each carton contains 10 vials.



6.6 Special precautions for disposal and other handling
See Table 1 for the recommended preparation and administration of Levebon 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 Levebon 100 mg/ml, concentrate for solution for infusion Dose       Withdrawal Volume                Volume of      Infusion Time Frequency of            Total Daily Diluent                        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.

Levebon 100 mg/ml concentrate for solution for infusion is physically compatible and chemically stable for 48 hours when mixed with the following diluents and stored at room temperature.
• Sodium chloride 9 mg/ml (0.9%) solution for injection
• Dextrose 50 mg/ml (5%) solution for injection
• Lactated Ringer’s solution for injection


If particles or discoloration occur, the product must not be used.

7. MARKETING AUTHORISATION HOLDER

A.L. Medi – Market Ltd., 3 Hakatif St., Emek Hefer Industrial Park , 3877701 , Israel 

8. MARKETING AUTHORISATION NUMBER
165-29-35845-00