Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical particulars
6.1 List of excipients

Mannitol

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.
The powder should be reconstituted immediately after opening of the vial.
The reconstituted concentrate should be diluted immediately with 0.9% sodium chloride solution.
Solution for infusion
After reconstitution and dilution, chemical and physical stability has been demonstrated for 3.5 hours at 25 °C and  2 days at 2 °C to 8 °C in polyethylene bags.
From a microbiological point of view, the solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

6.4 Special precautions for storage

Store below 25˚C
Keep the vial in the outer carton in order to protect from light.
For storage conditions of the reconstituted or diluted medicinal product, see section 6.3.
6.5 Nature and contents of container

Dark amber tubular flat bottom vial type I glass with gray rubber stopper and an aluminium flip -off seal.

10 ml-vials contain 25 mg bendamustine hydrochloride and are supplied in packs of 5, 10 and 20 vials.
50 ml-vials contain 100 mg bendamustine hydrochloride and are supplied in packs of 1 and 5 vials.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

When handling Demustin, inhalation, skin contact or contact with mucous membranes should be avoided (wear gloves and protective clothes!). Contaminated body parts should be carefully rinsed with water and soap, the eyes should be rinsed with physiological saline solution. If possible it is recommended to work on special safety workbenches (laminar flow) with liquid-impermeable, absorbent disposable foil. Pregnant personnel should be excluded from handling cytostatics.
The powder for concentrate for solution for infusion has to be reconstituted with water for injection, diluted with sodium chloride 9 mg/ml (0.9%) solution for injection and then administered by intravenous infusion. Aseptic technique is to be used.
1. Reconstitution
The powder should be reconstituted immediately after opening of the vial.
Reconstitute each vial of Demustin containing 25 mg bendamustine hydrochloride in 10 ml water for injection by shaking;
Reconstitute each vial of Demustin containing 100 mg bendamustine hydrochloride in 40 ml water for injection by shaking.
The reconstituted concentrate contains 2.5 mg bendamustine hydrochloride per ml and appears as a clear colourless solution.
2. Dilution
As soon as a clear solution is obtained (usually after 5-10 minutes) dilute the total recommended dose of Demustin immediately with 0.9% NaCl solution to produce a final volume of about 500 ml.
Demustin must be diluted with 0.9% NaCl solution and not with any other injectable solution.
3. Administration
The solution is administered by intravenous infusion over 30-60 min.
The vials are for single use only.
Any unused product or waste material should be disposed of in accordance with local requirements.