Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sodium chloride
Water for injections

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

Compatibility studies have shown potential for adsorption of dexmedetomidine to some types of natural rubber. Although dexmedetomidine is dosed to effect, it is advisable to use components with synthetic or coated natural rubber gaskets.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
After dilution
Chemical and physical stability of the diluted infusion (Infusion Solution Stability) has been demonstrated for 48 hours at 25°C and at refrigerated conditions (2 °C – 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 the use are the responsibility of the user and would not normally be longer than 24 hours at 2° to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Keep the ampoules or vials in the outer carton in order to protect from light.

For storage conditions after dilution of the medicinal product, see section 6.3 
6.5   Nature and contents of containers

2 and 4 ml Type I colourless glass ampoules (with filling volumes of 2 and 4 ml)
2 and 4 ml Type I colourless glass vials (with filling volumes of 2 and 4 ml), bromobutyl rubber closure with fluoropolymer coating
Pack sizes

5 x 2 ml ampoules

5 x 4 ml ampoules
5 x 2 ml vials

5 x 4 ml vials

Not all pack sizes may be marketed.
6.6     Special precautions for disposal and other handling

Ampoules and vials are intended for single patient use only.

Preparation of solution
Dexmedetomidine EVER Pharma can be diluted in glucose 50 mg/ml (5%), Ringers, mannitol or sodium chloride 9 mg/ml (0.9%) solution for injection to achieve the required concentration of either 4 micrograms/ml or 8 micrograms/ml prior to administration. Please see below in tabulated form the volumes needed to prepare the infusion.

In case the required concentration is 4 micrograms/ml:

Volume of
Dexmedetomidine EVER
Pharma 100 mcg/ml             Volume of diluent        Total volume of infusion concentrate for solution for infusion
2 ml                      48 ml                          50 ml
4 ml                      96 ml                          100 ml
10 ml                     240 ml                         250 ml
20 ml                     480 ml                         500 ml

In case the required concentration is 8 micrograms/ml:

Volume of
Dexmedetomidine EVER
Pharma 100 mcg/ml            Volume of diluent         Total volume of infusion concentrate for solution for infusion
4 ml                      46 ml                          50 ml
8 ml                      92 ml                         100 ml
20 ml                    230 ml                         250 ml
40 ml                    460 ml                         500 ml

The solution should be shaken gently to mix well.

Dexmedetomidine EVER Pharma should be inspected visually for particulate matter and discoloration prior to administration.

Dexmedetomidine EVER Pharma has been shown to be compatible when administered with the following intravenous fluids and medicinal products:

Lactated Ringers, 5% glucose solution, sodium chloride 9 mg/ml (0.9%) solution for injection, mannitol 200 mg/ml (20%), thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate bromide, phenylephrine HCl, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, fentanyl citrate, and a plasma-substitute.

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