Pharmaceutical particulars : מידע רוקחי

6      PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ethanol, anhydrous
Povidone K12
Citric acid, anhydrous

6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products or diluents except those stated in section 6.6.

6.3 Shelf-life
The expiry date of the product is printed on the package materials.
After dilution
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C and at 2°C to 8°C.
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 8ºC, unless dilution has taken place in controlled and validated aseptic conditions. Storage and in-use time after dilution should never exceed 24 hours.

6.4 Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze.
The colour of the concentrate may turn to orange during storage, but there is no loss of potency and the product may be used until the indicated expiry date if storage instructions have been followed.
For storage conditions of the diluted medicinal product, see section 6.3.

6.5 Nature and contents of container
     5 ml solution in clear colourless 8 ml Type I glass vial closed with bromobutyl rubber stopper with fluoropolymer coating.

Pack sizes
 1, 4, 10 vials of 5 ml.

Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Levosimendan MBI 2.5 mg/ml concentrate for solution for infusion is intended for single use only. Levosimendan MBI 2.5 mg/ml concentrate for solution for infusion should not be diluted into a higher concentration than 0.05 mg/ml as instructed below, otherwise opalescence and precipitation may occur.
As for all parenteral medicinal products, inspect the diluted solution visually for particulate matter and discolouration prior to administration.
To prepare the 0.025 mg/ml infusion, mix 5 ml of Levosimendan MBI 2.5 mg/ml concentrate for solution for infusion with 500 ml of 5% glucose solution.
To prepare the 0.05 mg/ml infusion, mix 10 ml of Levosimendan MBI 2.5 mg/ml concentrate for solution for infusion with 500 ml of 5% glucose solution.

Levosimendan MBI 2.5 mg/ml has been demonstrated to be compatible with 5% glucose solutions in PVC, PE, PP and PE/PP copolymer containers over a 24 hour period at either refrigerated or ambient temperatures. The compatibility with different types of PVC and non-PVC IV bags and tubing has also been demonstrated. The diluted product does not need light protection.

The following medicinal products can be given simultaneously with Levosimendan MBI in connected intravenous lines:
 Furosemide 10 mg/ml
 Digoxin 0.25 mg/ml
 Glyceryl trinitrate 0.1 mg/ml