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.
Solution for infusion
After reconstitution and dilution, chemical and physical stability has been demonstrated for 3.5 hours at 25 ºC/ 60% RH and 2 days at 2 ºC to 8 ºC in polyethylene bags.

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 ºC to 8 ºC, unless reconstitution/dilution(etc) has taken place in controlled and validated aseptic conditions.

6.4         Special precautions for storage

Store below 30°C.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after reconstitution or dilution of the medicinal product, see section 6.3.

6.5         Nature and contents of container

Type I amber glass vial of 25 ml with bromobutyl rubber stopper and aluminium cap with flip-top.
Type I amber glass vial of 50 ml with bromobutyl rubber stopper and aluminium cap with flip-top.
Not all pack sizes may be marketed.
6.6         Special precautions for disposal and other handling

When handling bendamustine hydrochloride, 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 Bendamustine medac 25 mg containing 25 mg bendamustine hydrochloride in 10 ml water for injection by shaking.

Reconstitute each vial of Bendamustine medac 100 mg 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 Bendamustine medac 25 mg or Bendamustine medac 100 mg immediately with 0.9% NaCl solution to produce a final volume of about 500 ml.

Bendamustine medac 25 mg or Bendamustine medac 100 mg 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.